Trial Outcomes & Findings for An Observational Study to Evaluate Efficacy and Safety of Risperidone Long-Acting Injection for Treatment of Schizophrenia (NCT NCT01894984)

NCT ID: NCT01894984

Last Updated: 2014-05-08

Results Overview

The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.

• Recruitment status: TERMINATED
• Target enrollment: 640 participants
• Primary outcome timeframe: Baseline and Week 24
• Results posted on: 2014-05-08

Participant Flow

Participant milestones

Measure	Risperidone Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor \[SSRI\]) was maintained and ceased at Week 3.	Oral Atypical Anti-psychotic Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
Overall Study STARTED	396	244
Overall Study COMPLETED	82	69
Overall Study NOT COMPLETED	314	175

Reasons for withdrawal

Measure	Risperidone Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor \[SSRI\]) was maintained and ceased at Week 3.	Oral Atypical Anti-psychotic Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
Overall Study Other	314	175

Baseline Characteristics

An Observational Study to Evaluate Efficacy and Safety of Risperidone Long-Acting Injection for Treatment of Schizophrenia

Baseline characteristics by cohort

Measure	Risperidone n=396 Participants Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor \[SSRI\]) was maintained and ceased at Week 3.	Oral Atypical Anti-psychotic n=243 Participants Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.	Total n=639 Participants Total of all reporting groups
Age, Continuous	27.4 Years STANDARD_DEVIATION 9.44 • n=5 Participants	32.2 Years STANDARD_DEVIATION 11.62 • n=7 Participants	29.2 Years STANDARD_DEVIATION 10.57 • n=5 Participants
Sex: Female, Male Female	190 Participants n=5 Participants	136 Participants n=7 Participants	326 Participants n=5 Participants
Sex: Female, Male Male	206 Participants n=5 Participants	107 Participants n=7 Participants	313 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Intent to treat (ITT) population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.

The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.

Outcome measures

Measure	Risperidone n=396 Participants Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor \[SSRI\]) was maintained and ceased at Week 3.	Oral Atypical Anti-psychotic n=243 Participants Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24 Baseline	74.7 units on a scale Standard Deviation 22.54	72.3 units on a scale Standard Deviation 20.49
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24 Change at Week 24	-36.5 units on a scale Standard Deviation 25.67	-38.2 units on a scale Standard Deviation 24.06

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.

The PSP is a clinician-rated scale that reflects social functioning in 4 domains of behavior (socially useful activities including work and study, personal and social relationships, self care, and disturbing and aggressive behaviors). The total score ranges from 1 to 100 (score of 71 to 100 will have a 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) divided into 10 equal intervals to rate the degree of difficulty (i=absent to vi=very severe) in each of the 4 domains.

Outcome measures

Measure	Risperidone n=396 Participants Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor \[SSRI\]) was maintained and ceased at Week 3.	Oral Atypical Anti-psychotic n=243 Participants Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
Total Personal and Social Performance (PSP) Score Baseline	52.1 units on a scale Standard Deviation 17.15	52.9 units on a scale Standard Deviation 16.00
Total Personal and Social Performance (PSP) Score Week 24	88.0 units on a scale Standard Deviation 10.25	82.3 units on a scale Standard Deviation 10.07

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.

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.

Outcome measures

Measure	Risperidone n=396 Participants Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor \[SSRI\]) was maintained and ceased at Week 3.	Oral Atypical Anti-psychotic n=243 Participants Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
Clinical Global Impressions-Severity (CGI-S) Score Week 24	1.5 units on a scale Standard Deviation 1.02	2.1 units on a scale Standard Deviation 1.14
Clinical Global Impressions-Severity (CGI-S) Score Baseline	4.5 units on a scale Standard Deviation 1.15	4.6 units on a scale Standard Deviation 1.12

SECONDARY outcome

Timeframe: Week 24

Population: ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.

Percentage of participants with relapse was assessed wherein relapse was defined as hospitalization due to the aggravation of psychiatric symptoms of disease condition.

Outcome measures

Measure	Risperidone n=396 Participants Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor \[SSRI\]) was maintained and ceased at Week 3.	Oral Atypical Anti-psychotic n=243 Participants Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
Percentage of Participants With Relapse at Week 24	0.5 Percentage of Participants 22.54	1.6 Percentage of Participants 20.49

SECONDARY outcome

Timeframe: Month 6

Population: ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.

Remission is defined as a clinical status where for each core symptoms (that are, delusions, conceptual disorganization, hallucinatory behavior, mannerisms and posturing unusual thought content, blunted affect, passive or apathetic social withdrawal and lack of spontaneity and flow of conversation) were assessed at a low-mild symptom intensity level, where such absent, borderline, or mild symptoms do not influence an individual's behavior.

Outcome measures

Measure	Risperidone n=396 Participants Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor \[SSRI\]) was maintained and ceased at Week 3.	Oral Atypical Anti-psychotic n=243 Participants Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
Percentage of Participants Attaining Remission Criteria	46 Percentage of Participants 22.54	68 Percentage of Participants 20.49

SECONDARY outcome

Timeframe: Month 6

Population: Analysis population included all enrolled participants.

Number of participants with reasons for discontinuation from study treatment is reported here because participants provided multiple reasons for discontinuation.

Outcome measures

Measure	Risperidone n=396 Participants Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor \[SSRI\]) was maintained and ceased at Week 3.	Oral Atypical Anti-psychotic n=244 Participants Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
Number of Participants With Reasons for Discontinuation From Study Treatment Physician Decision	14 Participants 22.54	11 Participants 20.49
Number of Participants With Reasons for Discontinuation From Study Treatment Adverse event	24 Participants	3 Participants
Number of Participants With Reasons for Discontinuation From Study Treatment Lack of efficacy	10 Participants	2 Participants
Number of Participants With Reasons for Discontinuation From Study Treatment Discontinuation from Treatment (more than 4 weeks)	65 Participants	7 Participants
Number of Participants With Reasons for Discontinuation From Study Treatment Added other anti-psychotics	10 Participants	3 Participants
Number of Participants With Reasons for Discontinuation From Study Treatment Change to other anti-psychotics	57 Participants	18 Participants
Number of Participants With Reasons for Discontinuation From Study Treatment Lost to follow-up	67 Participants	39 Participants
Number of Participants With Reasons for Discontinuation From Study Treatment Withdrawal by participant	4 Participants	0 Participants
Number of Participants With Reasons for Discontinuation From Study Treatment Other (unspecified)	128 Participants	106 Participants

Adverse Events

Risperidone

Serious events: 11 serious events

Other events: 73 other events

Deaths: 0 deaths

Oral Atypical Anti-psychotic

Serious events: 0 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Measure	Risperidone n=396 participants at risk Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor \[SSRI\]) was maintained and ceased at Week 3.	Oral Atypical Anti-psychotic n=244 participants at risk Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
Psychiatric disorders Auditory hallucination	0.76% 3/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	0.00% 0/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.
Nervous system disorders Headache	0.25% 1/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	0.00% 0/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.
Nervous system disorders Nervousness	0.25% 1/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	0.00% 0/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.
Psychiatric disorders Schizophrenia	1.5% 6/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	0.00% 0/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.
Psychiatric disorders Persecutory delusion	0.25% 1/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	0.00% 0/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.
Psychiatric disorders Agitation	0.25% 1/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	0.00% 0/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.
Psychiatric disorders Insomnia	0.25% 1/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	0.00% 0/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.25% 1/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	0.00% 0/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.
Psychiatric disorders Abnormal behaviour	0.25% 1/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	0.00% 0/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.
Psychiatric disorders Hallucination	0.25% 1/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	0.00% 0/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.

Other adverse events

Measure	Risperidone n=396 participants at risk Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor \[SSRI\]) was maintained and ceased at Week 3.	Oral Atypical Anti-psychotic n=244 participants at risk Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
Metabolism and nutrition disorders Hyperlipemia	0.00% 0/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	1.2% 3/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.
Investigations Weight gain	2.0% 8/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	2.5% 6/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.
Nervous system disorders Extrapyramidal disease	7.6% 30/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	7.8% 19/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.
Psychiatric disorders Anxiety	0.25% 1/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	1.2% 3/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.
Psychiatric disorders Schizophrenia	1.8% 7/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	0.00% 0/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.
Psychiatric disorders Akathisia	1.8% 7/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	0.41% 1/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.
Psychiatric disorders Somnolence	0.25% 1/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	1.2% 3/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.
Reproductive system and breast disorders Amenorrhea	2.8% 11/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	0.41% 1/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.
Reproductive system and breast disorders Menstrual disorder	2.0% 8/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	0.82% 2/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.
Gastrointestinal disorders Constipation	0.00% 0/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	2.5% 6/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.
Gastrointestinal disorders Hygrostomia	0.00% 0/396 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.	1.6% 4/244 • Baseline up to Week 24 Safety population included all randomized participants who had at least baseline evaluations.

Additional Information

Medical affairs director

XIAN-JANSSEN PHARMACEUTICAL

Phone: 86-10-58218307

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60