Schizophrenia
Conditions
Keywords
Schizophrenia, Paliperidone Extended Release (ER)
Brief summary
The purpose of this study is to evaluate the effectiveness of paliperidone ER for the treatment of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.
Detailed description
This is a multi-center (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), prospective (study following participants forward in time), non-comparative study. The total study duration will be 12 weeks for each participant and will include following visits: Screening, Week 2, 4, 8, and 12 (end of treatment or early withdrawal). The effectiveness of paliperidone ER will be evaluated at Week 12 by the proportion of responders who are evaluated as very much improved or much improved on the Clinical Global Impression improvement (CGI-I) Scale. Participants' safety will also be monitored throughout the study.
Interventions
DRUGPaliperidone ER
Participants will receive paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment will be done at Week 2, 4 and 8 as per investigator's discretion based upon participant's CGI-I score.
Sponsors
Johnson & Johnson Taiwan Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants who are diagnosed with schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders \[Edition 4\] criteria) * Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening * Childbearing potential women who consented to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) * Participants who are capable of and willing to fill out the questionnaire for themselves * Participants who are compliant with self-medication or can receive consistent help or support
Exclusion criteria
* Participants with the past history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness) * Participants with allergy or hypersensitivity to risperidone or paliperidone * Participants who have taken clozapine, or have been exposed to the study drug within one month before screening * Participants who have been treated with the long acting antipsychotic injection within 28 days * Participants with significant risk including suicide or aggressive behavior
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale | Week 12 | The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Responders were defined as participants evaluated as 1: very much improved or 2: much improved on the CGI-I scale at Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12 | Baseline, Week 12 | The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening. |
| Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score | Week 12 | The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. |
| Change From Baseline in Personal and Social Performance (PSP) Score at Week 12 | Baseline, Week 12 | The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). |
| Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12 | Baseline, Week 12 | The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response (SR). A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive SR; a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paliperidone ER Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's CGI-I score. | 353 |
| Total | 353 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 9 |
| Overall Study | Lack of Efficacy | 15 |
| Overall Study | Lost to Follow-up | 40 |
| Overall Study | Other | 9 |
| Overall Study | Subject Uncooperative | 7 |
| Overall Study | Withdrawal by Subject | 18 |
Baseline characteristics
| Characteristic | Paliperidone ER |
|---|---|
| Age, Continuous | 41.1 years STANDARD_DEVIATION 11.2 |
| Sex: Female, Male Female | 132 Participants |
| Sex: Female, Male Male | 221 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 140 / 353 |
| serious Total, serious adverse events | 0 / 353 |
Outcome results
Primary
Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Responders were defined as participants evaluated as 1: very much improved or 2: much improved on the CGI-I scale at Week 12.
Time frame: Week 12
Population: Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paliperidone Extended Release (ER) | Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale | 21.6 percentage of participants |
Secondary
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening.
Time frame: Baseline, Week 12
Population: ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12 | Baseline (n=331) | 5.0 units on a scale | Standard Deviation 0.8 |
| Paliperidone Extended Release (ER) | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12 | Change at Week 12 (n=255) | -1.4 units on a scale | Standard Deviation 1 |
Secondary
Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12
The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response (SR). A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive SR; a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
Time frame: Baseline, Week 12
Population: ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) | Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12 | Baseline (n=331) | 2.5 units on a scale | Standard Deviation 4.6 |
| Paliperidone Extended Release (ER) | Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12 | Change at Week 12 (n=267) | 1.0 units on a scale | Standard Deviation 4.9 |
Secondary
Change From Baseline in Personal and Social Performance (PSP) Score at Week 12
The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).
Time frame: Baseline, Week 12
Population: ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) | Change From Baseline in Personal and Social Performance (PSP) Score at Week 12 | Change at Week 12 (n=267) | 14.3 units on a scale | Standard Deviation 13 |
| Paliperidone Extended Release (ER) | Change From Baseline in Personal and Social Performance (PSP) Score at Week 12 | Baseline (n=331) | 42.6 units on a scale | Standard Deviation 14.9 |
Secondary
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Time frame: Week 12
Population: ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) | Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score | Minimally improved | 119 participants | — |
| Paliperidone Extended Release (ER) | Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score | No change | 67 participants | — |
| Paliperidone Extended Release (ER) | Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score | Minimally worse | 10 participants | — |
| Paliperidone Extended Release (ER) | Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score | Much worse | 2 participants | — |
| Paliperidone Extended Release (ER) | Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score | Very much improved | 3 participants | 0.9 |
| Paliperidone Extended Release (ER) | Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score | Much improved | 52 participants | — |
| Paliperidone Extended Release (ER) | Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score | Very much worse | 2 participants | — |