Trial Outcomes & Findings for An Efficacy and Safety Study of Risperidone Long-Acting Microspheres in Participants With Schizophrenia, Schizophreniform or Schizoaffective Disorders (NCT NCT01855074)

NCT ID: NCT01855074

Last Updated: 2013-08-14

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. Change at Week 26 score is calculated as Baseline score minus Week 26 score.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 80 participants
• Primary outcome timeframe: Baseline and Week 26
• Results posted on: 2013-08-14

Participant Flow

Participant milestones

Measure	Risperidone Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
Overall Study STARTED	80
Overall Study Treated	79
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	Risperidone Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	8
Overall Study Started but not treated	1

Baseline Characteristics

An Efficacy and Safety Study of Risperidone Long-Acting Microspheres in Participants With Schizophrenia, Schizophreniform or Schizoaffective Disorders

Baseline characteristics by cohort

Measure	Risperidone n=79 Participants Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
Age Continuous	43.0 Years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 26

Population: The Intent-to-treat (ITT) population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here 'n' signifies number of participants evaluable for this outcome measure at specific time point.

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. Change at Week 26 score is calculated as Baseline score minus Week 26 score.

Outcome measures

Measure	Risperidone n=78 Participants Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 Baseline (n=78)	68.9 Units on a scale Standard Deviation 15.8
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 Change at Week 26 (n=66)	28.1 Units on a scale Standard Deviation 17.1

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: The Intent-to-treat (ITT) population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here 'n' signifies number of participants evaluable for this outcome measure at specific time point.

The CGI 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=78 Participants Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
Clinical Global Impressions (CGI) - Disease Severity Score Baseline (n=78)	4.2 Units on a scale Standard Deviation 4.0
Clinical Global Impressions (CGI) - Disease Severity Score Week 26 (n=66)	2.9 Units on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: The ITT population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.

The SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: vitality, physical function, social function, physical role, emotional role, bodily pain, general health, mental health. Each item is scored on a scale ranging from 0-100 (100=highest level of functioning).

Outcome measures

Measure	Risperidone n=78 Participants Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
Short Form-36 (SF-36) - Quality of Life Score Week 26; Mental health (n=66)	59.9 Units on a scale Standard Deviation 12.8
Short Form-36 (SF-36) - Quality of Life Score Baseline; Physical function (n=78)	78.3 Units on a scale Standard Deviation 21.7
Short Form-36 (SF-36) - Quality of Life Score Week 26; Physical function (n=66)	90.5 Units on a scale Standard Deviation 13.8
Short Form-36 (SF-36) - Quality of Life Score Baseline; Physical role (n=78)	41.0 Units on a scale Standard Deviation 46.5
Short Form-36 (SF-36) - Quality of Life Score Week 26; Physical role (n=66)	75.4 Units on a scale Standard Deviation 41.0
Short Form-36 (SF-36) - Quality of Life Score Baseline; Body pain (n=78)	86.2 Units on a scale Standard Deviation 19.8
Short Form-36 (SF-36) - Quality of Life Score Week 26; Body pain (n=66)	94.7 Units on a scale Standard Deviation 11.8
Short Form-36 (SF-36) - Quality of Life Score Baseline; General health (n=78)	51.7 Units on a scale Standard Deviation 18.3
Short Form-36 (SF-36) - Quality of Life Score Week 26; General health (n=66)	67.8 Units on a scale Standard Deviation 12.0
Short Form-36 (SF-36) - Quality of Life Score Baseline; Vitality (n=78)	51.7 Units on a scale Standard Deviation 16.8
Short Form-36 (SF-36) - Quality of Life Score Week 26; Vitality (n=66)	58.6 Units on a scale Standard Deviation 11.5
Short Form-36 (SF-36) - Quality of Life Score Baseline; Social function (n=78)	49.0 Units on a scale Standard Deviation 20.4
Short Form-36 (SF-36) - Quality of Life Score Week 26; Social function (n=66)	74.1 Units on a scale Standard Deviation 18.1
Short Form-36 (SF-36) - Quality of Life Score Baseline; Emotional role (n=78)	32.1 Units on a scale Standard Deviation 46.0
Short Form-36 (SF-36) - Quality of Life Score Week 26; Emotional role (n=66)	73.2 Units on a scale Standard Deviation 42.3
Short Form-36 (SF-36) - Quality of Life Score Baseline; Mental health (n=78)	50.7 Units on a scale Standard Deviation 13.8

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: The ITT population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.

The GAF is a 100-point tool to measure overall psychological, social and occupational functioning of adults. The higher score range (91 to 100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1 to 10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.

Outcome measures

Measure	Risperidone n=78 Participants Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
Global Assessment of Functioning (GAF) Score Baseline (n=78)	56.5 Units on a scale Standard Deviation 14.2
Global Assessment of Functioning (GAF) Score Week 26 (n=66)	69.4 Units on a scale Standard Deviation 11.7

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: The ITT population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.

Participants' were assessed for their satisfaction with the current antipsychotic treatment on a 5-point scale/questionnaire: very good, good, reasonable, moderate or poor.

Outcome measures

Measure	Risperidone n=78 Participants Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
Patient Satisfaction With Treatment Baseline; Very good (n=78)	2 Participants
Patient Satisfaction With Treatment Week 26; Very good (n=66)	16 Participants
Patient Satisfaction With Treatment Baseline; Good (n=78)	13 Participants
Patient Satisfaction With Treatment Week 26; Good (n=66)	40 Participants
Patient Satisfaction With Treatment Baseline; Moderate (n=78)	42 Participants
Patient Satisfaction With Treatment Week 26; Moderate (n=66)	10 Participants
Patient Satisfaction With Treatment Baseline; Poor (n=78)	19 Participants
Patient Satisfaction With Treatment Baseline; Very poor (n=78)	1 Participants
Patient Satisfaction With Treatment Baseline; No available (n=78)	1 Participants

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Safety set (SS) population (N=79) included all participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, absent) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.

Outcome measures

Measure	Risperidone n=78 Participants Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
Extrapyramidal Symptom Rating Scale (ESRS) Score Baseline	12.9 Units on a scale Standard Deviation 9.6
Extrapyramidal Symptom Rating Scale (ESRS) Score Week 26	9.2 Units on a scale Standard Deviation 5.1

Adverse Events

Risperidone

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Risperidone n=79 participants at risk Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
Psychiatric disorders Psychotic disorder	1.3% 1/79 Safety set (SS) population (N=79) included all participants who received at least 1 dose of study drug.

Other adverse events

Measure	Risperidone n=79 participants at risk Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
Nervous system disorders Extrapyramidal disorder	1.3% 1/79 Safety set (SS) population (N=79) included all participants who received at least 1 dose of study drug.

Additional Information

Medical Manager Neurosciences

Janssen. Pharmaceutical Companies of Johnson and Johnson

Phone: +507-3989740

Email: dmuschet@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee All the information generated through services from the Principal Investigator (PI), the Sponsor has the rights to publish the data without previous consent from the PI. The PI must not publish completely or partially any results from the study, without previous authorization from the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER