Schizophrenia
Conditions
Keywords
Schizophrenia, Paliperidone Extended Release (ER), INVEGA
Brief summary
The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) treatment in Thai 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 an open-label (all people know the identity of the intervention), non-randomized (the study drug is not assigned by chance) study to evaluate the efficacy and safety of paliperidone ER in adult Thai schizophrenia participants. The study consists of a screening phase and an open-label treatment phase. Study duration will be 10 weeks and participants can either be inpatient or outpatient. The recommended paliperidone ER starting and maintenance dose will be 6 milligram (mg) per day for most participants. Throughout the study, flexible dosing ranging from 3 to 12 mg per day may be used at the discretion of the investigator. Throughout the study, participants will be evaluated for efficacy using clinician rating (Clinical and Global Impressions-Severity \[CGI-S\] scale, and Personal and Social Performance Scale \[PSP\]) scales. Safety of the participants will be monitored.
Interventions
Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks
Sponsors
Janssen-Cilag Ltd.,Thailand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) * Participants unsatisfied with their previous treatment * Previously or currently on oral atypical antipsychotics
Exclusion criteria
* Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities * History or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body) * 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) * Pregnant or breast-feeding female * Participation in an investigational drug trial within 30 days prior to selection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale at Week 10 | Baseline, Week 10 | 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 . |
| Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 2 | Baseline, Week 2 | The PSP scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. 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. |
| Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 6 | Baseline, Week 6 | The PSP scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. 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. |
| Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 10 | Baseline, Week 10 | The PSP scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. 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. |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paliperidone Extended Release (ER) Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Changed diagnosis | 1 |
| Overall Study | Insufficient response | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Non-compliant | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Paliperidone Extended Release (ER) |
|---|---|
| Age Continuous | 41.13 Years STANDARD_DEVIATION 12.314 |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 22 / 40 |
| serious Total, serious adverse events | 1 / 40 |
Outcome results
Primary
Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale at Week 10
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 10
Population: Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) | Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale at Week 10 | Change at Week 10 | 0.82 Units on a scale | Standard Deviation 1.036 |
| Paliperidone Extended Release (ER) | Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale at Week 10 | Baseline | 3.55 Units on a scale | Standard Deviation 1.155 |
p-value: 0Friedman test
Primary
Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 10
The PSP scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. 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.
Time frame: Baseline, Week 10
Population: Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Extended Release (ER) | Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 10 | -9.868 Units on a scale | Standard Deviation 14.64 |
p-value: 0Paired t-test
Primary
Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 2
The PSP scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. 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.
Time frame: Baseline, Week 2
Population: Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) | Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 2 | Baseline | 58.95 Units on a scale | Standard Deviation 15.71 |
| Paliperidone Extended Release (ER) | Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 2 | Change at Week 2 | -4.289 Units on a scale | Standard Deviation 9.647 |
p-value: 0.009Paired t-test
Primary
Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 6
The PSP scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. 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.
Time frame: Baseline, Week 6
Population: Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Extended Release (ER) | Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 6 | -7.053 Units on a scale | Standard Deviation 11.463 |
p-value: 0.001Paired t-test