Trial Outcomes & Findings for Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (NCT NCT00330863)
NCT ID: NCT00330863
Last Updated: 2018-07-10
Results Overview
Brief Psychiatric Rating Scale (BPRS) psychosis cluster. Score range is based on the score range for individual items rather than the factor total because is factors have different numbers of items. Score range is 1 -7 where 1 + no symptomatology and 7 = very severe symptoms.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
357 participants
Primary outcome timeframe
Measured throughout study up to 30 months
Results posted on
2018-07-10
Participant Flow
357 individuals consented to participation. However, 52 were either ineligible, withdrew consent, or lost to followup. Therefore, 305 individuals were randomized.
Participant milestones
| Measure |
Injectable
Participants assigned to receive long-acting injectable risperidone
Risperidone microspheres: Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.
|
Oral
Participants assigned to receive oral "atypical" antipsychotic medication
Risperidone: Target dose is 4 mg/day.
Olanzapine: Target dose is 15 mg/day.
Quetiapine: Target dose is 600 mg/day.
Ziprasidone: Target dose is 120 mg/day.
Aripiprazole: Target dose is 20 mg/day.
Paliperidone: Target dose is 6 mg/day.
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
152
|
|
Overall Study
COMPLETED
|
72
|
72
|
|
Overall Study
NOT COMPLETED
|
81
|
80
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy
Baseline characteristics by cohort
| Measure |
Injectable
n=153 Participants
Participants assigned to receive long-acting injectable risperidone
Risperidone microspheres: Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.
|
Oral
n=152 Participants
Participants assigned to receive oral "atypical" antipsychotic medication
Risperidone: Target dose is 4 mg/day.
Olanzapine: Target dose is 15 mg/day.
Quetiapine: Target dose is 600 mg/day.
Ziprasidone: Target dose is 120 mg/day.
Aripiprazole: Target dose is 20 mg/day.
Paliperidone: Target dose is 6 mg/day.
|
Total
n=305 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.18 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
38.23 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
38.2 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
81 participants
n=5 Participants
|
78 participants
n=7 Participants
|
159 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
45 participants
n=5 Participants
|
40 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
27 participants
n=5 Participants
|
31 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
153 participants
n=5 Participants
|
152 participants
n=7 Participants
|
305 participants
n=5 Participants
|
|
Clinical Global Impressions (CGI) Severity Scale
|
4.1 units on a scale
STANDARD_DEVIATION 0.84 • n=5 Participants
|
4.0 units on a scale
STANDARD_DEVIATION 0.77 • n=7 Participants
|
4.04 units on a scale
STANDARD_DEVIATION 0.80 • n=5 Participants
|
PRIMARY outcome
Timeframe: Measured throughout study up to 30 monthsPopulation: We conducted a mixed model regression analysis with two treatment groups X time psychosis cluster scores at each 3 monthly observation from baseline to 30 months. Missing data were treated as MAR
Brief Psychiatric Rating Scale (BPRS) psychosis cluster. Score range is based on the score range for individual items rather than the factor total because is factors have different numbers of items. Score range is 1 -7 where 1 + no symptomatology and 7 = very severe symptoms.
Outcome measures
| Measure |
Injectable
n=153 Participants
Participants assigned to receive long-acting injectable risperidone
Risperidone microspheres: Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.
|
Oral
n=152 Participants
Participants assigned to receive oral "atypical" antipsychotic medication
Risperidone: Target dose is 4 mg/day.
Olanzapine: Target dose is 15 mg/day.
Quetiapine: Target dose is 600 mg/day.
Ziprasidone: Target dose is 120 mg/day.
Aripiprazole: Target dose is 20 mg/day.
Paliperidone: Target dose is 6 mg/day.
|
|---|---|---|
|
Substantial Clinical Deterioration Measured by Psychotic Symptoms
|
1.8 units on a scale
Interval 1.7 to 1.9
|
2.0 units on a scale
Interval 1.9 to 2.2
|
SECONDARY outcome
Timeframe: Measured throughout study up to 30 monthsOutcome measures
| Measure |
Injectable
n=153 Participants
Participants assigned to receive long-acting injectable risperidone
Risperidone microspheres: Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.
|
Oral
n=152 Participants
Participants assigned to receive oral "atypical" antipsychotic medication
Risperidone: Target dose is 4 mg/day.
Olanzapine: Target dose is 15 mg/day.
Quetiapine: Target dose is 600 mg/day.
Ziprasidone: Target dose is 120 mg/day.
Aripiprazole: Target dose is 20 mg/day.
Paliperidone: Target dose is 6 mg/day.
|
|---|---|---|
|
Number of Patients Discontinuing From the Study
|
81 participants
|
80 participants
|
SECONDARY outcome
Timeframe: Measured throughout study up to 30 monthsPopulation: These data were not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured throughout study up to 30 monthsPopulation: These data were not collected. No data displayed because Outcome Measure has zero total participants analyzed.
Brief Psychiatric Rating Scale (BPRS) total score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured throughout study up to 30 monthsPopulation: No data displayed because Outcome Measure has zero total participants analyzed. Data not collected.
Scale of Functioning (SOF)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured throughout study up to 30 monthsThe highest severity of each of 24 adverse event (AE) that was assessed.over the 30 month study period. The mean severity on a scale of 1 (none) to 4 very severe symptom was recorded at each biweekly visit. Results for each variable are summarized over time so that each subject has a single mean severity rating for each AE. There is no named scale. Each of the side effects measured is named in ways that are clear to medical readers e.g anorexia. The range is 1 none to 4 very severe. Therefore, a higher scale score is worse.
Outcome measures
| Measure |
Injectable
n=143 Participants
Participants assigned to receive long-acting injectable risperidone
Risperidone microspheres: Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.
|
Oral
n=148 Participants
Participants assigned to receive oral "atypical" antipsychotic medication
Risperidone: Target dose is 4 mg/day.
Olanzapine: Target dose is 15 mg/day.
Quetiapine: Target dose is 600 mg/day.
Ziprasidone: Target dose is 120 mg/day.
Aripiprazole: Target dose is 20 mg/day.
Paliperidone: Target dose is 6 mg/day.
|
|---|---|---|
|
Side Effects and Metabolic Measures
Tremor
|
1.77 units on a scale
Standard Deviation 0.72
|
1.75 units on a scale
Standard Deviation 0.80
|
|
Side Effects and Metabolic Measures
Bruising easily
|
1.43 units on a scale
Standard Deviation 0.71
|
1.48 units on a scale
Standard Deviation 0.75
|
|
Side Effects and Metabolic Measures
Rash
|
1.53 units on a scale
Standard Deviation 0.78
|
1.44 units on a scale
Standard Deviation 0.71
|
|
Side Effects and Metabolic Measures
Urticaria (hives, itching)
|
1.60 units on a scale
Standard Deviation 0.69
|
1.71 units on a scale
Standard Deviation 0.84
|
|
Side Effects and Metabolic Measures
Blurred vision
|
1.76 units on a scale
Standard Deviation 0.73
|
1.91 units on a scale
Standard Deviation 0.83
|
|
Side Effects and Metabolic Measures
sedation/drowsiness
|
2.34 units on a scale
Standard Deviation 0.87
|
2.53 units on a scale
Standard Deviation 0.78
|
|
Side Effects and Metabolic Measures
Restlessness
|
2.48 units on a scale
Standard Deviation 0.76
|
2.43 units on a scale
Standard Deviation 0.82
|
|
Side Effects and Metabolic Measures
Insomnia
|
2.38 units on a scale
Standard Deviation 0.89
|
2.36 units on a scale
Standard Deviation 0.94
|
|
Side Effects and Metabolic Measures
Malaise (weakness, fatigue)
|
2.22 units on a scale
Standard Deviation 0.85
|
2.14 units on a scale
Standard Deviation 0.87
|
|
Side Effects and Metabolic Measures
Stiffness
|
2.01 units on a scale
Standard Deviation 0.82
|
1.97 units on a scale
Standard Deviation 0.85
|
|
Side Effects and Metabolic Measures
Dizziness
|
1.82 units on a scale
Standard Deviation 0.79
|
1.78 units on a scale
Standard Deviation 0.82
|
|
Side Effects and Metabolic Measures
Headache
|
1.99 units on a scale
Standard Deviation 0.88
|
1.89 units on a scale
Standard Deviation 0.90
|
|
Side Effects and Metabolic Measures
Fever
|
1.27 units on a scale
Standard Deviation 0.49
|
1.24 units on a scale
Standard Deviation 0.46
|
|
Side Effects and Metabolic Measures
Sore Throat
|
1.64 units on a scale
Standard Deviation 0.78
|
1.57 units on a scale
Standard Deviation 0.69
|
|
Side Effects and Metabolic Measures
Dry Mouth
|
2.36 units on a scale
Standard Deviation 0.92
|
2.25 units on a scale
Standard Deviation 0.94
|
|
Side Effects and Metabolic Measures
Hypersalivation
|
1.76 units on a scale
Standard Deviation 0.80
|
1.84 units on a scale
Standard Deviation 0.94
|
|
Side Effects and Metabolic Measures
Enuresis
|
1.63 units on a scale
Standard Deviation 0.89
|
1.56 units on a scale
Standard Deviation 0.83
|
|
Side Effects and Metabolic Measures
Constipation
|
1.75 units on a scale
Standard Deviation 0.86
|
1.64 units on a scale
Standard Deviation 0.82
|
|
Side Effects and Metabolic Measures
Diarrhea
|
1.65 units on a scale
Standard Deviation 0.86
|
1.68 units on a scale
Standard Deviation 0.81
|
|
Side Effects and Metabolic Measures
Anorexia (loss of appetite)
|
1.89 units on a scale
Standard Deviation 0.86
|
1.69 units on a scale
Standard Deviation 0.84
|
|
Side Effects and Metabolic Measures
Nausea
|
1.78 units on a scale
Standard Deviation 0.82
|
1.72 units on a scale
Standard Deviation 0.80
|
|
Side Effects and Metabolic Measures
Vomiting
|
1.48 units on a scale
Standard Deviation 0.72
|
1.51 units on a scale
Standard Deviation 0.76
|
|
Side Effects and Metabolic Measures
Menstrual Irregularity
|
1.62 units on a scale
Standard Deviation 0.96
|
1.55 units on a scale
Standard Deviation 0.86
|
|
Side Effects and Metabolic Measures
Breast tenderness/galactorrhea
|
1.39 units on a scale
Standard Deviation 0.69
|
1.32 units on a scale
Standard Deviation 0.61
|
Adverse Events
Injectable
Serious events: 61 serious events
Other events: 143 other events
Deaths: 0 deaths
Oral
Serious events: 48 serious events
Other events: 148 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Injectable
n=143 participants at risk；n=146 participants at risk
Participants assigned to receive long-acting injectable risperidone
Risperidone microspheres: Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.
|
Oral
n=148 participants at risk；n=150 participants at risk
Participants assigned to receive oral "atypical" antipsychotic medication
Risperidone: Target dose is 4 mg/day.
Olanzapine: Target dose is 15 mg/day.
Quetiapine: Target dose is 600 mg/day.
Ziprasidone: Target dose is 120 mg/day.
Aripiprazole: Target dose is 20 mg/day.
Paliperidone: Target dose is 6 mg/day.
|
|---|---|---|
|
Psychiatric disorders
first relapse often hospitalization
|
41.8%
61/146
305 participants were randomized. However, 9 never received study medication. Therefore, SAE results are reported for 296 participants. 5 subjects did not have postbaseline AE ratings, and therefore AE results are reported for 291 participants.
|
32.0%
48/150
305 participants were randomized. However, 9 never received study medication. Therefore, SAE results are reported for 296 participants. 5 subjects did not have postbaseline AE ratings, and therefore AE results are reported for 291 participants.
|
Other adverse events
| Measure |
Injectable
n=143 participants at risk；n=146 participants at risk
Participants assigned to receive long-acting injectable risperidone
Risperidone microspheres: Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.
|
Oral
n=148 participants at risk；n=150 participants at risk
Participants assigned to receive oral "atypical" antipsychotic medication
Risperidone: Target dose is 4 mg/day.
Olanzapine: Target dose is 15 mg/day.
Quetiapine: Target dose is 600 mg/day.
Ziprasidone: Target dose is 120 mg/day.
Aripiprazole: Target dose is 20 mg/day.
Paliperidone: Target dose is 6 mg/day.
|
|---|---|---|
|
Psychiatric disorders
anorexia
|
100.0%
143/143
305 participants were randomized. However, 9 never received study medication. Therefore, SAE results are reported for 296 participants. 5 subjects did not have postbaseline AE ratings, and therefore AE results are reported for 291 participants.
|
100.0%
148/148
305 participants were randomized. However, 9 never received study medication. Therefore, SAE results are reported for 296 participants. 5 subjects did not have postbaseline AE ratings, and therefore AE results are reported for 291 participants.
|
Additional Information
Peter F. Buckley, MD
Medical College of Georgia, Georgia Regents University
Phone: 706-721-2231
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place