Schizophrenia
Conditions
Brief summary
The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relapse in participants with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.).
Detailed description
The primary hypothesis of this study is that the efficacy of PP6M is non-inferior to PP3M for preventing relapse in participants with schizophrenia who were previously stabilized on corresponding doses of PP1M or PP3M. The study consists of mainly 3 phases: a screening phase (up to 28 days), a maintenance phase (of 1 or 3 months), and a double-blind phase (of 12 months \[neither the researchers nor the participants know what treatment the participant is receiving\]). Additional/conditional phases include a transition phase (before maintenance phase). Study evaluations include efficacy, pharmacokinetics, pharmacodynamics, and safety. The study duration will vary from approximately 13 months to 19 months.
Interventions
DRUGPP6M
Participants will receive intramuscular injection of PP6M.
DRUGPP3M 350 mg eq.
Participants will receive intramuscular injection of PP3M 350 mg eq.
DRUGPP3M 525 mg eq.
Participants will receive intramuscular injection of PP3M 525 mg eq.
DRUGPP1M
Participants will receive intramuscular injection of PP1M 50 to 150 mg eq.
OTHERPlacebo
Participants will receive matching placebo.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Must meet the diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) for at least 6 months before screening * Must be receiving treatment with paliperidone palmitate (as either the paliperidone palmitate 1-month (PP1M) or paliperidone palmitate 3-month (PP3M) formulation), or injectable risperidone, or any oral antipsychotic * Must be able, in the opinion of the investigator, to discontinue any antipsychotic medication other than PP1M) or PP3M during the Screening Phase * Must have a full Positive and Negative Syndrome Scale (PANSS) score of less than (\<) 70 points at screening * Must have a body mass index (BMI) between 17 and 40 kilogram (kg)/meter (m)\^2 (inclusive) and must have a body weight of at least 47 kg at screening * Must be willing to receive gluteal injections of medication during the Double-blind Phase
Exclusion criteria
* Must not be receiving any form of involuntary treatment, such as involuntary psychiatric hospitalization, parole-mandated treatment, or court-mandated treatment * Must not have attempted suicide within 12 months before screening and must not be at imminent risk of suicide or violent behavior, as clinically assessed by the investigator at the time of screening * Must not have a DSM-5 diagnosis of moderate or severe substance use disorder (except for nicotine and caffeine) within 6 months of screening; however, acute or intermittent substance use prior to screening is not exclusionary, depending upon the clinical judgment of the investigator * Must not have a history of neuroleptic malignant syndrome or tardive dyskinesia * Must not have a history of intolerability or severe reactions to moderate or higher doses of antipsychotic medications and must not have any other factors that would, in the judgment of the investigator, indicate that treatment with moderate or higher doses of paliperidone palmitate would be intolerable or unsafe
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Relapse During the Double-Blind (DB) Phase | Up to 12 months of DB Phase | Time to relapse is time between participant randomization in DB Phase and first documentation of relapse event by end of Month 12 of DB phase. Relapse is defined as: a) Psychiatric hospitalization; b) Positive and Negative Syndrome Scale (PANSS) total score: Increase of 25 percentage (%), 10 point increase in PANSS for 2 analysis separated by 3-7 days if score was greater than (\>) 40, less than or equal to (\<=)40; c) Participants inflicted knowing self-injury/shown violent behavior leading to suicide, clinically significant injury to him/herself or other person/property; d) Participants had suicidal/homicidal ideation/violent behavior that was clinically significant as per investigator; e) PANSS items P1- delusions, P2- conceptual disorganization, P3-hallucinatory behavior, P6- suspiciousness/ persecution, P7-hostility, G8-uncooperativeness: score: greater than or equal to (\>=)5, \>=6 for 2 analysis separated by 3-7 days on any items if maximum score for PANSS: \<=3 or 4, respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score | Baseline (DB) to 12 Months of DB Phase | CGI-S is defined as clinician-rated scale that assesses the severity of mental illness on a scale of 0 to 7. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to:1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; 7: among the most extremely ill patients. A higher score implies a more severe condition. |
| Change From Baseline in the Personal and Social Performance (PSP) Scale Total Score | Baseline (DB) to 12 Months of DB Phase | The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: 1) socially useful activities, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. Each domain was assessed on a 6-point scale, from 1 (absent) to 6 (very severe) (1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe). PSP total score was calculated as sum of all the domain scores and ranges from 1 to 100. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. Higher score indicates better performance. |
| Percentage of Participants With Symptomatic Remission Based on PANSS Score During DB Phase | Up to 12 months of DB Phase | Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity. The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. |
| Change From Baseline in the Satisfaction With Participants in Social Roles (SPSR) Score | Baseline (DB) to 12 Months of DB Phase | The SPSR Short Form 8a is a participant-reported outcome used to assess the satisfaction with participation in social roles. The participants were asked to rate 8 items on 5-point Likert scale, with scores ranging from 8 to 40, where higher scores represents higher satisfaction. |
| Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score | Baseline (DB) to 12 Months of DB Phase | TSQM-9 consists of 9 questions to assess patients' satisfaction with medication using a range of responses from 1 (extremely dissatisfied) to (7 extremely satisfied). This patient reported outcome provides scores on three parts: effectiveness, convenience, and global satisfaction. The sum of the 9-questions were calculated and used for analysis. The total score ranges from 0 to 63, with higher scores indicating better treatment satisfaction. |
| Change From Baseline in the Simpson-Angus Rating Scale (SAS) Total Score | Baseline (DB) to 12 Months of DB Phase | The SAS rates 10 items for general extrapyramidal symptoms (EPS) on a 5-point scale from 0 (normal) to 4 (extreme), including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head rotation, Glabellar tap, tremor, and salivation. The SAS total score is the average score (total sum of item scores divided by the number of items) and ranges between 0 and 4. Negative change in score indicates improvement. Higher scores denote more severe condition of EPS. |
| Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score | Up to 12 Months of DB Phase | BARS is used to rate observable, restless movements of drug induced akathisia and subjective awareness of restlessness and any distress associated with the akathisia. BARS consists of the following 4 items: objective assessment of akathisia symptoms, subjective assessment of the participants's awareness of inner restlessness, distress restlessness, and global clinical assessment of akathisia. First three items are rated on a 4-point scale ranging from 0 (no abnormal movements or absence of inner restlessness or no distress) to 3 (severe akathisia or awareness of intense compulsion to move most of the time or severe distress). The last item, the global clinical assessment of akathisia, is rated on a 6-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). |
| Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Total Score | Baseline (DB) to 12 Months of DB Phase | AIMS is a 14-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant's incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 to 14 are yes/no questions regarding the global judgement and dental status of the participant. The total score is the sum of the scores for the 14 items and the possible total score ranges from 0 to 44. A higher total score is indicative of more severe dyskinetic movements. |
| Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline and endpoint (12 Months of DB Phase) | The C-SSRS is a questionnaire used for suicide risk assessment. Affirmative or negative responses are provided to items 1 to 5 for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods \[not plan\] without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and items 6 to 10 for suicide behavior (6. Preparatory acts or behavior, 7. Aborted attempt, 8. Interrupted attempt, 9. Actual attempt, 10. Completed suicide). Total score ranges from 1 to 10. Higher scores indicate more severe suicidal ideation. |
| Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline (DB) to 12 Months of DB Phase | The neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale, which provides a total score (sum of the scores for all 30 items) and scores for 3 subscales: the 7-item positive-symptom (P) subscale, the 7-item negative-symptom (N) subscale, and the 16-item general-psychopathology symptom (G) subscale. Each item is rated on a scale from 1 (absent) to 7 (extreme). The PANSS total score ranges from 30 (absent disease)-210 (more severe neuropsychiatric symptoms of schizophrenia). |
| Change From Baseline in the Body Mass Index (BMI) During DB Phase | Baseline (DB) to 12 Months of DB Phase | Change from baseline in BMI was reported. |
| Change From Baseline in the Waist Circumference During DB Phase | Baseline (DB) to 12 Months of DB Phase | Change from baseline in waist circumference was reported. |
| Change From Baseline in the Body Weight During DB Phase | Baseline (DB) to 12 Months of DB Phase | Change from baseline in body weight was reported. |
| Change From Baseline in the Vital Signs (Pulse Rate) During DB Phase | Baseline (DB) to 12 Months of DB Phase | Change from baseline vital signs (pulse rate) were reported. This included supine pulse rate, standing pulse rate and supine-standing pulse rate. |
| Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase | Baseline (DB) to 12 Months of DB Phase | Change from baseline in vital signs including SBP and DBP (supine/standing) were reported. |
| Change From Baseline in Positive and Syndrome Scale (PANSS) Subscales Score During DB Phase | Baseline (DB) to 12 Months of DB Phase | The neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale, which provides a total score (sum of the scores for all 30 items) and Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology). |
| Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Up to 12 Months of DB Phase | Number of participants with clinically significant abnormal laboratory values in chemistry included alanine aminotransferase (Unit per Litre \[U/L\]), albumin (Gram per Litre \[g/L\]), alkaline phosphatase (U/L), aspartate aminotransferase (U/L), bicarbonate (millimoles per litre \[mmol/L\]), bilirubin (micromoles per litre \[umol/L\]), calcium (mmol/L), chloride (mmol/L), cholesterol (mmol/L), creatinine (umol/L), gamma glutamyl transferase (GGT) (U/L), glucose (mmol/L), high-density lipoproteins (HDL) cholesterol (mmol/L), low density lipoproteins (LDL) cholesterol (mmol/L), lactate dehydrogenase (U/L), phosphate (mmol/L), potassium (mmol/L), protein (mmol/L), sodium (mmol/L), triglycerides (mmol/L), urate (umol/L), urea nitrogen (mmol/L) were reported. Here, ABL signifies abnormally low and ABH signifies abnormally high levels. |
| Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Up to 12 Months of DB Phase | Number of participants with clinically significant abnormal laboratory values in hematology included hemoglobin (Hb), hematocrit (Hct), red blood cell (RBC) count, white blood cell (WBC) count with differential, platelets, hemoglobin A1c. Here, ABL signifies abnormally low and ABH signifies abnormally high levels. |
| Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase | Baseline (DB) to 12 Months of DB Phase | Number of participants with treatment-emergent abnormal ECG values were reported. It includes heart rate (abnormally low refers to less than or equal to \[\<=\] 50 beats per minute (bpm) , abnormally high refers greater than or equal to \[\>=\] 100 bpm), pulse rate (PR) interval (abnormally high refers to \>= 210 milliseconds \[msec\]), QRS interval (abnormally Low refers to \<= 50, abnormally high refers to \>= 120 msec) and QT interval (abnormally low refers to \<= 200, abnormally high \>= 500 msec). |
Countries
Argentina, Australia, Brazil, Bulgaria, Czechia, France, Hong Kong, Hungary, India, Italy, Malaysia, Mexico, Poland, Russia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United States
Participant flow
Pre-assignment details
Total 841 participants were enrolled, out of which 838 participants received treatment. 2 participants were enrolled but did not receive treatment and 1 participant withdrew from the Open-label Phase and as permitted per the protocol, re-entered the study (under a different participant identifier) and was counted twice in the total. Per the rules specified in statistical analysis plan, only data collected during the second study participation was included in data summary for this participant.
Participants by arm
| Arm | Count |
|---|---|
| Open-Label (OL) PP1M/PP3M Participants previously treated with oral antipsychotics, or injectable risperidone, or a moderate or higher dose of paliperidone palmitate 1-month (PP1M) with previous initiation but without previous stabilization (where stabilization was defined as at least 3 months of injections with the last 2 doses being the same strength) received 1 to 5 intramuscular (IM) injections of PP1M 50 to 150 milligrams equivalent (mg eq.). Participants received single dose of IM injection of PP1M as 100 or 150 mg eq. or PP3M as 350 or 525 mg eq during the OL-maintenance phase. | 838 |
| Total | 838 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Double-Blind Phase | Adverse Event | 0 | 1 | 6 | 0 | 0 |
| Double-Blind Phase | Death | 0 | 2 | 1 | 0 | 0 |
| Double-Blind Phase | Initiated Prohibited Medication | 0 | 0 | 2 | 0 | 0 |
| Double-Blind Phase | Lost to Follow-up | 0 | 1 | 7 | 0 | 0 |
| Double-Blind Phase | Other | 0 | 1 | 3 | 0 | 0 |
| Double-Blind Phase | Physician Decision | 0 | 1 | 4 | 0 | 0 |
| Double-Blind Phase | Protocol Violation | 0 | 0 | 1 | 0 | 0 |
| Double-Blind Phase | Withdrawal by Subject | 0 | 16 | 38 | 0 | 0 |
| Follow-Up Phase | Adverse Event | 0 | 0 | 0 | 0 | 4 |
| Follow-Up Phase | Lost to Follow-up | 0 | 0 | 0 | 0 | 6 |
| Follow-Up Phase | Other | 0 | 0 | 0 | 3 | 1 |
| Follow-Up Phase | Physician Decision | 0 | 0 | 0 | 0 | 5 |
| Follow-Up Phase | Withdrawal by Subject | 0 | 0 | 0 | 5 | 15 |
| Open-Label Phase | Adverse Event | 30 | 0 | 0 | 0 | 0 |
| Open-Label Phase | Death | 1 | 0 | 0 | 0 | 0 |
| Open-Label Phase | Initiated Prohibited Medication | 2 | 0 | 0 | 0 | 0 |
| Open-Label Phase | Lack of Efficacy | 6 | 0 | 0 | 0 | 0 |
| Open-Label Phase | Lost to Follow-up | 9 | 0 | 0 | 0 | 0 |
| Open-Label Phase | Non-Compliance with Study Drug | 4 | 0 | 0 | 0 | 0 |
| Open-Label Phase | Other | 15 | 0 | 0 | 0 | 0 |
| Open-Label Phase | Physician Decision | 4 | 0 | 0 | 0 | 0 |
| Open-Label Phase | Protocol Violation | 8 | 0 | 0 | 0 | 0 |
| Open-Label Phase | Withdrawal by Subject | 57 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Open-Label (OL) PP1M/PP3M |
|---|---|
| Age, Continuous | 40.8 years STANDARD_DEVIATION 11.68 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 118 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 710 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 111 Participants |
| Race (NIH/OMB) Black or African American | 106 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 606 Participants |
| Region of Enrollment ARGENTINA | 55 Participants |
| Region of Enrollment AUSTRALIA | 4 Participants |
| Region of Enrollment BRAZIL | 90 Participants |
| Region of Enrollment BULGARIA | 46 Participants |
| Region of Enrollment CZECH REPUBLIC | 45 Participants |
| Region of Enrollment FRANCE | 7 Participants |
| Region of Enrollment HONG KONG | 4 Participants |
| Region of Enrollment HUNGARY | 20 Participants |
| Region of Enrollment INDIA | 42 Participants |
| Region of Enrollment ITALY | 8 Participants |
| Region of Enrollment KOREA, REPUBLIC OF | 4 Participants |
| Region of Enrollment MALAYSIA | 22 Participants |
| Region of Enrollment MEXICO | 23 Participants |
| Region of Enrollment POLAND | 68 Participants |
| Region of Enrollment RUSSIAN FEDERATION | 139 Participants |
| Region of Enrollment SPAIN | 29 Participants |
| Region of Enrollment TAIWAN | 31 Participants |
| Region of Enrollment TURKEY | 26 Participants |
| Region of Enrollment UKRAINE | 50 Participants |
| Region of Enrollment UNITED STATES | 125 Participants |
| Sex: Female, Male Female | 285 Participants |
| Sex: Female, Male Male | 553 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 838 | 2 / 224 | 1 / 478 | 0 / 42 | 0 / 109 |
| other Total, other adverse events | 127 / 838 | 52 / 224 | 125 / 478 | 1 / 42 | 5 / 109 |
| serious Total, serious adverse events | 23 / 838 | 15 / 224 | 24 / 478 | 1 / 42 | 6 / 109 |
Outcome results
Primary
Time to Relapse During the Double-Blind (DB) Phase
Time to relapse is time between participant randomization in DB Phase and first documentation of relapse event by end of Month 12 of DB phase. Relapse is defined as: a) Psychiatric hospitalization; b) Positive and Negative Syndrome Scale (PANSS) total score: Increase of 25 percentage (%), 10 point increase in PANSS for 2 analysis separated by 3-7 days if score was greater than (\>) 40, less than or equal to (\<=)40; c) Participants inflicted knowing self-injury/shown violent behavior leading to suicide, clinically significant injury to him/herself or other person/property; d) Participants had suicidal/homicidal ideation/violent behavior that was clinically significant as per investigator; e) PANSS items P1- delusions, P2- conceptual disorganization, P3-hallucinatory behavior, P6- suspiciousness/ persecution, P7-hostility, G8-uncooperativeness: score: greater than or equal to (\>=)5, \>=6 for 2 analysis separated by 3-7 days on any items if maximum score for PANSS: \<=3 or 4, respectively.
Time frame: Up to 12 months of DB Phase
Population: DB Intent-to-Treat (ITT) analysis set included participants who were randomly assigned to paliperidone palmitate 6-month (PP6M) /paliperidone palmitate 3-month (PP3M) during DB Phase, received at least 1 dose of PP6M/PP3M.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DB PP3M | Time to Relapse During the Double-Blind (DB) Phase | NA Days |
| DB PP6M | Time to Relapse During the Double-Blind (DB) Phase | NA Days |
Secondary
Change From Baseline in Positive and Syndrome Scale (PANSS) Subscales Score During DB Phase
The neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale, which provides a total score (sum of the scores for all 30 items) and Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).
Time frame: Baseline (DB) to 12 Months of DB Phase
Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB PP3M | Change From Baseline in Positive and Syndrome Scale (PANSS) Subscales Score During DB Phase | Positive Subscale Score | -0.1 units on a scale | Standard Deviation 2.82 |
| DB PP3M | Change From Baseline in Positive and Syndrome Scale (PANSS) Subscales Score During DB Phase | Negative Subscale Score | -0.6 units on a scale | Standard Deviation 2.61 |
| DB PP3M | Change From Baseline in Positive and Syndrome Scale (PANSS) Subscales Score During DB Phase | General Psychopathology Subscale Score | -0.9 units on a scale | Standard Deviation 4.18 |
| DB PP6M | Change From Baseline in Positive and Syndrome Scale (PANSS) Subscales Score During DB Phase | Positive Subscale Score | -0.1 units on a scale | Standard Deviation 3.3 |
| DB PP6M | Change From Baseline in Positive and Syndrome Scale (PANSS) Subscales Score During DB Phase | Negative Subscale Score | -0.7 units on a scale | Standard Deviation 2.7 |
| DB PP6M | Change From Baseline in Positive and Syndrome Scale (PANSS) Subscales Score During DB Phase | General Psychopathology Subscale Score | -1.0 units on a scale | Standard Deviation 4.86 |
Secondary
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Total Score
AIMS is a 14-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant's incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 to 14 are yes/no questions regarding the global judgement and dental status of the participant. The total score is the sum of the scores for the 14 items and the possible total score ranges from 0 to 44. A higher total score is indicative of more severe dyskinetic movements.
Time frame: Baseline (DB) to 12 Months of DB Phase
Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DB PP3M | Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Total Score | 0.0 units on a scale |
| DB PP6M | Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Total Score | 0.0 units on a scale |
Secondary
Change From Baseline in the Body Mass Index (BMI) During DB Phase
Change from baseline in BMI was reported.
Time frame: Baseline (DB) to 12 Months of DB Phase
Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB PP3M | Change From Baseline in the Body Mass Index (BMI) During DB Phase | 0.3 kilogram per meter square (kg/m^2) | Standard Deviation 1.78 |
| DB PP6M | Change From Baseline in the Body Mass Index (BMI) During DB Phase | 0.0 kilogram per meter square (kg/m^2) | Standard Deviation 1.72 |
Secondary
Change From Baseline in the Body Weight During DB Phase
Change from baseline in body weight was reported.
Time frame: Baseline (DB) to 12 Months of DB Phase
Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB PP3M | Change From Baseline in the Body Weight During DB Phase | 0.96 kilogram (kg) | Standard Deviation 5.103 |
| DB PP6M | Change From Baseline in the Body Weight During DB Phase | 0.10 kilogram (kg) | Standard Deviation 4.959 |
Secondary
Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score
CGI-S is defined as clinician-rated scale that assesses the severity of mental illness on a scale of 0 to 7. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to:1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; 7: among the most extremely ill patients. A higher score implies a more severe condition.
Time frame: Baseline (DB) to 12 Months of DB Phase
Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB PP3M | Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score | 0.0 units on a scale | Standard Deviation 0.63 |
| DB PP6M | Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score | 0.0 units on a scale | Standard Deviation 0.7 |
Secondary
Change From Baseline in the Personal and Social Performance (PSP) Scale Total Score
The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: 1) socially useful activities, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. Each domain was assessed on a 6-point scale, from 1 (absent) to 6 (very severe) (1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe). PSP total score was calculated as sum of all the domain scores and ranges from 1 to 100. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. Higher score indicates better performance.
Time frame: Baseline (DB) to 12 Months of DB Phase
Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB PP3M | Change From Baseline in the Personal and Social Performance (PSP) Scale Total Score | 1.1 units on a scale | Standard Deviation 8.11 |
| DB PP6M | Change From Baseline in the Personal and Social Performance (PSP) Scale Total Score | 1.0 units on a scale | Standard Deviation 7.12 |
Secondary
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score
The neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale, which provides a total score (sum of the scores for all 30 items) and scores for 3 subscales: the 7-item positive-symptom (P) subscale, the 7-item negative-symptom (N) subscale, and the 16-item general-psychopathology symptom (G) subscale. Each item is rated on a scale from 1 (absent) to 7 (extreme). The PANSS total score ranges from 30 (absent disease)-210 (more severe neuropsychiatric symptoms of schizophrenia).
Time frame: Baseline (DB) to 12 Months of DB Phase
Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB PP3M | Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score | -1.6 units on a scale | Standard Deviation 7.4 |
| DB PP6M | Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score | -1.8 units on a scale | Standard Deviation 8.92 |
Secondary
Change From Baseline in the Satisfaction With Participants in Social Roles (SPSR) Score
The SPSR Short Form 8a is a participant-reported outcome used to assess the satisfaction with participation in social roles. The participants were asked to rate 8 items on 5-point Likert scale, with scores ranging from 8 to 40, where higher scores represents higher satisfaction.
Time frame: Baseline (DB) to 12 Months of DB Phase
Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB PP3M | Change From Baseline in the Satisfaction With Participants in Social Roles (SPSR) Score | 0.9 units on a scale | Standard Deviation 7.15 |
| DB PP6M | Change From Baseline in the Satisfaction With Participants in Social Roles (SPSR) Score | 0.6 units on a scale | Standard Deviation 6.58 |
Secondary
Change From Baseline in the Simpson-Angus Rating Scale (SAS) Total Score
The SAS rates 10 items for general extrapyramidal symptoms (EPS) on a 5-point scale from 0 (normal) to 4 (extreme), including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head rotation, Glabellar tap, tremor, and salivation. The SAS total score is the average score (total sum of item scores divided by the number of items) and ranges between 0 and 4. Negative change in score indicates improvement. Higher scores denote more severe condition of EPS.
Time frame: Baseline (DB) to 12 Months of DB Phase
Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DB PP3M | Change From Baseline in the Simpson-Angus Rating Scale (SAS) Total Score | 0.00 units on a scale |
| DB PP6M | Change From Baseline in the Simpson-Angus Rating Scale (SAS) Total Score | 0.00 units on a scale |
Secondary
Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score
TSQM-9 consists of 9 questions to assess patients' satisfaction with medication using a range of responses from 1 (extremely dissatisfied) to (7 extremely satisfied). This patient reported outcome provides scores on three parts: effectiveness, convenience, and global satisfaction. The sum of the 9-questions were calculated and used for analysis. The total score ranges from 0 to 63, with higher scores indicating better treatment satisfaction.
Time frame: Baseline (DB) to 12 Months of DB Phase
Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB PP3M | Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score | Convenience | 3.4 units on a scale | Standard Deviation 17.76 |
| DB PP3M | Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score | Effectiveness | 6.0 units on a scale | Standard Deviation 21.18 |
| DB PP3M | Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score | Overall satisfaction | 2.5 units on a scale | Standard Deviation 19.29 |
| DB PP6M | Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score | Effectiveness | 3.6 units on a scale | Standard Deviation 19.49 |
| DB PP6M | Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score | Convenience | 1.1 units on a scale | Standard Deviation 15.3 |
| DB PP6M | Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score | Overall satisfaction | 0.5 units on a scale | Standard Deviation 20.02 |
Secondary
Change From Baseline in the Vital Signs (Pulse Rate) During DB Phase
Change from baseline vital signs (pulse rate) were reported. This included supine pulse rate, standing pulse rate and supine-standing pulse rate.
Time frame: Baseline (DB) to 12 Months of DB Phase
Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB PP3M | Change From Baseline in the Vital Signs (Pulse Rate) During DB Phase | Supine Pulse Rate | 1.2 beats per minute (bpm) | Standard Deviation 11.57 |
| DB PP3M | Change From Baseline in the Vital Signs (Pulse Rate) During DB Phase | Standing Pulse Rate | 2.6 beats per minute (bpm) | Standard Deviation 12.28 |
| DB PP3M | Change From Baseline in the Vital Signs (Pulse Rate) During DB Phase | Pulse Rate (Standing-Supine) | 1.5 beats per minute (bpm) | Standard Deviation 8.85 |
| DB PP6M | Change From Baseline in the Vital Signs (Pulse Rate) During DB Phase | Supine Pulse Rate | 0.6 beats per minute (bpm) | Standard Deviation 11.56 |
| DB PP6M | Change From Baseline in the Vital Signs (Pulse Rate) During DB Phase | Standing Pulse Rate | 0.9 beats per minute (bpm) | Standard Deviation 12.6 |
| DB PP6M | Change From Baseline in the Vital Signs (Pulse Rate) During DB Phase | Pulse Rate (Standing-Supine) | 0.2 beats per minute (bpm) | Standard Deviation 8.31 |
Secondary
Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase
Change from baseline in vital signs including SBP and DBP (supine/standing) were reported.
Time frame: Baseline (DB) to 12 Months of DB Phase
Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB PP3M | Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase | Supine SBP | -0.3 millimetre of mercury (mmHg) | Standard Deviation 13.14 |
| DB PP3M | Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase | Standing SBP | 0.8 millimetre of mercury (mmHg) | Standard Deviation 12.08 |
| DB PP3M | Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase | SBP (Standing-Supine) | 1.0 millimetre of mercury (mmHg) | Standard Deviation 9.83 |
| DB PP3M | Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase | Supine DBP | 0.1 millimetre of mercury (mmHg) | Standard Deviation 9.25 |
| DB PP3M | Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase | Standing DBP | 0.3 millimetre of mercury (mmHg) | Standard Deviation 9.39 |
| DB PP3M | Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase | DBP (Standing-Supine) | 0.2 millimetre of mercury (mmHg) | Standard Deviation 7.79 |
| DB PP6M | Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase | Standing DBP | 0.4 millimetre of mercury (mmHg) | Standard Deviation 7.48 |
| DB PP6M | Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase | Supine SBP | 0.6 millimetre of mercury (mmHg) | Standard Deviation 9.96 |
| DB PP6M | Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase | Supine DBP | -0.4 millimetre of mercury (mmHg) | Standard Deviation 7.49 |
| DB PP6M | Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase | Standing SBP | 1.3 millimetre of mercury (mmHg) | Standard Deviation 10.4 |
| DB PP6M | Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase | DBP (Standing-Supine) | 0.7 millimetre of mercury (mmHg) | Standard Deviation 6.43 |
| DB PP6M | Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase | SBP (Standing-Supine) | 0.6 millimetre of mercury (mmHg) | Standard Deviation 7.32 |
Secondary
Change From Baseline in the Waist Circumference During DB Phase
Change from baseline in waist circumference was reported.
Time frame: Baseline (DB) to 12 Months of DB Phase
Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB PP3M | Change From Baseline in the Waist Circumference During DB Phase | 0.82 centimeter (cm) | Standard Deviation 5.137 |
| DB PP6M | Change From Baseline in the Waist Circumference During DB Phase | 0.37 centimeter (cm) | Standard Deviation 5.157 |
Secondary
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score
The C-SSRS is a questionnaire used for suicide risk assessment. Affirmative or negative responses are provided to items 1 to 5 for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods \[not plan\] without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and items 6 to 10 for suicide behavior (6. Preparatory acts or behavior, 7. Aborted attempt, 8. Interrupted attempt, 9. Actual attempt, 10. Completed suicide). Total score ranges from 1 to 10. Higher scores indicate more severe suicidal ideation.
Time frame: Baseline and endpoint (12 Months of DB Phase)
Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'n' (number analyzed) included all evaluable participants who were analyzed for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (0= No event) | 218 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (6= Preparatory acts/behavior) | 0 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (1= Wish to be dead) | 1 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (2= Non-specific suicidal thought) | 0 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (2= Non-specific suicidal thought) | 0 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (7= Aborted attempt) | 0 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (3= Suicidal ideation-no intent) | 0 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (4= Ideation with intent, no plan) | 0 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (4= Ideation with intent, no plan) | 1 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (8= Interrupted attempt) | 0 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (5= Ideation with plan/intent) | 1 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (1= Wish to be dead) | 3 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (6= Preparatory acts/behavior) | 0 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (9= Actual attempt) | 0 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (7= Aborted attempt) | 0 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (5= Ideation with plan/intent) | 0 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (8= Interrupted attempt) | 0 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (10= Suicide) | 0 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (9= Actual attempt) | 0 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (3= Suicidal ideation-no intent) | 0 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (10= Suicide) | 0 Participants |
| DB PP3M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (0= No event) | 221 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (10= Suicide) | 0 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (0= No event) | 477 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (1= Wish to be dead) | 0 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (2= Non-specific suicidal thought) | 1 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (3= Suicidal ideation-no intent) | 0 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (4= Ideation with intent, no plan) | 0 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (5= Ideation with plan/intent) | 0 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (6= Preparatory acts/behavior) | 0 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (7= Aborted attempt) | 0 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (8= Interrupted attempt) | 0 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (9= Actual attempt) | 0 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | Baseline (10= Suicide) | 0 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (0= No event) | 471 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (1= Wish to be dead) | 1 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (2= Non-specific suicidal thought) | 0 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (3= Suicidal ideation-no intent) | 1 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (4= Ideation with intent, no plan) | 0 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (5= Ideation with plan/intent) | 2 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (6= Preparatory acts/behavior) | 0 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (7= Aborted attempt) | 0 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (8= Interrupted attempt) | 0 Participants |
| DB PP6M | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | End Point (9= Actual attempt) | 1 Participants |
Secondary
Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score
BARS is used to rate observable, restless movements of drug induced akathisia and subjective awareness of restlessness and any distress associated with the akathisia. BARS consists of the following 4 items: objective assessment of akathisia symptoms, subjective assessment of the participants's awareness of inner restlessness, distress restlessness, and global clinical assessment of akathisia. First three items are rated on a 4-point scale ranging from 0 (no abnormal movements or absence of inner restlessness or no distress) to 3 (severe akathisia or awareness of intense compulsion to move most of the time or severe distress). The last item, the global clinical assessment of akathisia, is rated on a 6-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia).
Time frame: Up to 12 Months of DB Phase
Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DB PP3M | Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score | Global Clinical Assessment | 185 Participants |
| DB PP3M | Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score | Objective | 185 Participants |
| DB PP3M | Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score | Subjective (Awareness) | 185 Participants |
| DB PP3M | Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score | Subjective (Distress) | 185 Participants |
| DB PP6M | Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score | Subjective (Distress) | 380 Participants |
| DB PP6M | Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score | Global Clinical Assessment | 380 Participants |
| DB PP6M | Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score | Subjective (Awareness) | 380 Participants |
| DB PP6M | Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score | Objective | 380 Participants |
Secondary
Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase
Number of participants with treatment-emergent abnormal ECG values were reported. It includes heart rate (abnormally low refers to less than or equal to \[\<=\] 50 beats per minute (bpm) , abnormally high refers greater than or equal to \[\>=\] 100 bpm), pulse rate (PR) interval (abnormally high refers to \>= 210 milliseconds \[msec\]), QRS interval (abnormally Low refers to \<= 50, abnormally high refers to \>= 120 msec) and QT interval (abnormally low refers to \<= 200, abnormally high \>= 500 msec).
Time frame: Baseline (DB) to 12 Months of DB Phase
Population: Double-blind safety analysis set (DB safety) included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DB PP3M | Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase | PR Duration value >= 210 | 3 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase | QRS Duration value >= 120 | 1 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase | Heart Rate value >=100 | 20 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase | QT Duration value <= 200 | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase | QRS Duration value <= 50 | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase | QT Duration value >= 500 | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase | Heart Rate value <=50 | 5 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase | QT Duration value >= 500 | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase | Heart Rate value <=50 | 9 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase | Heart Rate value >=100 | 36 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase | PR Duration value >= 210 | 8 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase | QRS Duration value <= 50 | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase | QRS Duration value >= 120 | 2 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase | QT Duration value <= 200 | 0 Participants |
Secondary
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase
Number of participants with clinically significant abnormal laboratory values in chemistry included alanine aminotransferase (Unit per Litre \[U/L\]), albumin (Gram per Litre \[g/L\]), alkaline phosphatase (U/L), aspartate aminotransferase (U/L), bicarbonate (millimoles per litre \[mmol/L\]), bilirubin (micromoles per litre \[umol/L\]), calcium (mmol/L), chloride (mmol/L), cholesterol (mmol/L), creatinine (umol/L), gamma glutamyl transferase (GGT) (U/L), glucose (mmol/L), high-density lipoproteins (HDL) cholesterol (mmol/L), low density lipoproteins (LDL) cholesterol (mmol/L), lactate dehydrogenase (U/L), phosphate (mmol/L), potassium (mmol/L), protein (mmol/L), sodium (mmol/L), triglycerides (mmol/L), urate (umol/L), urea nitrogen (mmol/L) were reported. Here, ABL signifies abnormally low and ABH signifies abnormally high levels.
Time frame: Up to 12 Months of DB Phase
Population: Double-Blind safety analysis set (DB safety) included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. Here 'n' (number analyzed) included all evaluable participants who were analyzed for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Calcium ABL | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Albumin ABL | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Albumin ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Alkaline Phosphatase ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Aspartate Aminotransferase ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Bicarbonate ABL | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Bicarbonate ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Bilirubin ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Alanine Aminotransferase ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Calcium ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Chloride ABL | 4 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Chloride ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Cholesterol ABH | 2 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Creatinine ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Gamma Glutamyl Transferase ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Glucose ABL | 1 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Glucose ABH | 1 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | HDL Cholesterol ABL | 18 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | LDL Cholesterol ABL | 33 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | LDL Cholesterol ABH | 9 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Lactate Dehydrogenase ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Phosphate ABL | 1 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Phosphate ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Potassium ABL | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Potassium ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Protein ABL | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Sodium ABL | 1 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Sodium ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Triglycerides ABH | 4 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Urate ABL | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Urate ABH | 1 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Urea Nitrogen ABH | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Urea Nitrogen ABH | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Alanine Aminotransferase ABH | 1 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Glucose ABH | 5 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Albumin ABL | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Potassium ABH | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Albumin ABH | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | HDL Cholesterol ABL | 40 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Alkaline Phosphatase ABH | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Triglycerides ABH | 6 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Aspartate Aminotransferase ABH | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | LDL Cholesterol ABL | 44 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Bicarbonate ABL | 3 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Protein ABL | 1 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Bicarbonate ABH | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | LDL Cholesterol ABH | 22 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Bilirubin ABH | 1 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Urate ABH | 4 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Calcium ABL | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Lactate Dehydrogenase ABH | 1 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Calcium ABH | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Sodium ABL | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Chloride ABL | 5 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Phosphate ABL | 8 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Chloride ABH | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Urate ABL | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Cholesterol ABH | 4 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Phosphate ABH | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Creatinine ABH | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Sodium ABH | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Gamma Glutamyl Transferase ABH | 2 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Potassium ABL | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Glucose ABL | 0 Participants |
Secondary
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase
Number of participants with clinically significant abnormal laboratory values in hematology included hemoglobin (Hb), hematocrit (Hct), red blood cell (RBC) count, white blood cell (WBC) count with differential, platelets, hemoglobin A1c. Here, ABL signifies abnormally low and ABH signifies abnormally high levels.
Time frame: Up to 12 Months of DB Phase
Population: Double-blind safety analysis set (DB safety) included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. Here 'n' (number analyzed) included all evaluable participants who were analyzed for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Eosinophils ABL | 1 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Leukocytes ABH | 2 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Hematocrit ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Lymphocytes ABL | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Erythrocytes ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Lymphocytes ABH | 1 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Hemoglobin ABL | 1 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Monocytes ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Erythrocytes ABL | 1 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Neutrophils ABL | 1 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Hemoglobin ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Neutrophils ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Hematocrit ABL | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Platelets ABL | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Leukocytes ABL | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Platelets ABH | 0 Participants |
| DB PP3M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Basophils ABL | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Platelets ABH | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Basophils ABL | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Eosinophils ABL | 1 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Erythrocytes ABL | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Erythrocytes ABH | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Hematocrit ABL | 1 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Hematocrit ABH | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Hemoglobin ABL | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Hemoglobin ABH | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Leukocytes ABL | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Leukocytes ABH | 4 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Lymphocytes ABL | 2 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Lymphocytes ABH | 1 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Monocytes ABH | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Neutrophils ABL | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Neutrophils ABH | 0 Participants |
| DB PP6M | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Platelets ABL | 0 Participants |
Secondary
Percentage of Participants With Symptomatic Remission Based on PANSS Score During DB Phase
Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity. The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.
Time frame: Up to 12 months of DB Phase
Population: DB ITT included all participants who were randomly assigned to treatment group of either PP6M or PP3M, received at least 1 dose of PP6M/PP3M.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB PP3M | Percentage of Participants With Symptomatic Remission Based on PANSS Score During DB Phase | 70.1 Percentage of participants |
| DB PP6M | Percentage of Participants With Symptomatic Remission Based on PANSS Score During DB Phase | 66.3 Percentage of participants |