Trial Outcomes & Findings for Comparison of Optimal Antipsychotic Treatments for Adults With Schizophrenia (NCT NCT00802100)
NCT ID: NCT00802100
Last Updated: 2013-02-08
Results Overview
Goal was to randomize 60 participants who met eligibility criteria.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
Baseline
Results posted on
2013-02-08
Participant Flow
This feasibility-focused pilot study was conducted at 14 clinical sites affiliated with the Schizophrenia Trials Network in 2008-9.
Participant milestones
| Measure |
Olanzapine
Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
Olanzapine dose 10-30 mg/day Metformin dose 850-2550 mg/day
|
Perphenazine
Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
Perphenazine dose 8-24 mg/day Benztropine dose 1-2 mg/day Metformin dose 850-2550 mg/day Simvistatin dose 20-40 mg/day
|
Aripiprazole
Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
Aripiprazole dose 10-30 mg/day Benztropine dose 1-2 mg/day Metformin dose 850-2550 mg/day Simvistatin dose 20-40 mg/day
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
6
|
|
Overall Study
COMPLETED
|
0
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Optimal Antipsychotic Treatments for Adults With Schizophrenia
Baseline characteristics by cohort
| Measure |
Olanzapine
n=6 Participants
Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
|
Perphenazine
n=9 Participants
Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
|
Aripiprazole
n=6 Participants
Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
30 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
30 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
27 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
29 years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Total study population
Goal was to randomize 60 participants who met eligibility criteria.
Outcome measures
| Measure |
Overall Study
n=21 Participants
This refers to the feasibility of the entire pilot study. Only 21 eligible participants of the goal of 60 were randomized because sites were unable to identify adequate numbers of eligible participants.
|
Perphenazine
Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
|
Aripiprazole
Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
|
|---|---|---|---|
|
Feasibility of Randomizing a Cohort of Participants Meeting the Inclusion and Exclusion Criteria of the Study
|
21 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured over 28 weeks of study visitsPopulation: Analysis population is those randomized. Outcome is discontinuation from study treatment before 28 weeks
Outcome measures
| Measure |
Overall Study
n=6 Participants
This refers to the feasibility of the entire pilot study. Only 21 eligible participants of the goal of 60 were randomized because sites were unable to identify adequate numbers of eligible participants.
|
Perphenazine
n=9 Participants
Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
|
Aripiprazole
n=6 Participants
Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
|
|---|---|---|---|
|
Antipsychotic Efficacy, Defined as Completion of the Trial Without Psychiatric Hospitalization, Clinician Decision to Discontinue Treatment, or Patient Decision to Discontinue Treatment
Unacceptable side effects
|
0 participants
|
0 participants
|
0 participants
|
|
Antipsychotic Efficacy, Defined as Completion of the Trial Without Psychiatric Hospitalization, Clinician Decision to Discontinue Treatment, or Patient Decision to Discontinue Treatment
Inefficacy
|
0 participants
|
1 participants
|
1 participants
|
|
Antipsychotic Efficacy, Defined as Completion of the Trial Without Psychiatric Hospitalization, Clinician Decision to Discontinue Treatment, or Patient Decision to Discontinue Treatment
Patient refusal
|
3 participants
|
0 participants
|
0 participants
|
|
Antipsychotic Efficacy, Defined as Completion of the Trial Without Psychiatric Hospitalization, Clinician Decision to Discontinue Treatment, or Patient Decision to Discontinue Treatment
Drop-out, no information available
|
2 participants
|
1 participants
|
0 participants
|
|
Antipsychotic Efficacy, Defined as Completion of the Trial Without Psychiatric Hospitalization, Clinician Decision to Discontinue Treatment, or Patient Decision to Discontinue Treatment
Administrative
|
1 participants
|
5 participants
|
3 participants
|
|
Antipsychotic Efficacy, Defined as Completion of the Trial Without Psychiatric Hospitalization, Clinician Decision to Discontinue Treatment, or Patient Decision to Discontinue Treatment
Completed trial without discontinuing
|
0 participants
|
2 participants
|
2 participants
|
Adverse Events
Olanzapine
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Perphenazine
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Aripiprazole
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olanzapine
n=6 participants at risk
Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
|
Perphenazine
n=9 participants at risk
Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
|
Aripiprazole
n=6 participants at risk
Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
|
|---|---|---|---|
|
Psychiatric disorders
Exacerbation of Schizophrenia
|
33.3%
2/6 • Number of events 2
|
22.2%
2/9 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Reproductive system and breast disorders
Uterine fibroids
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
Other adverse events
| Measure |
Olanzapine
n=6 participants at risk
Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
|
Perphenazine
n=9 participants at risk
Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
|
Aripiprazole
n=6 participants at risk
Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
|
|---|---|---|---|
|
Psychiatric disorders
Akathisia/activation
|
66.7%
4/6 • Number of events 4
|
77.8%
7/9 • Number of events 7
|
100.0%
6/6 • Number of events 6
|
|
General disorders
Sleepiness
|
50.0%
3/6 • Number of events 3
|
100.0%
9/9 • Number of events 9
|
83.3%
5/6 • Number of events 5
|
|
General disorders
Weight gain
|
50.0%
3/6 • Number of events 3
|
88.9%
8/9 • Number of events 8
|
100.0%
6/6 • Number of events 6
|
|
General disorders
Dry mouth
|
50.0%
3/6 • Number of events 3
|
66.7%
6/9 • Number of events 6
|
83.3%
5/6 • Number of events 5
|
|
General disorders
Increased appetite
|
16.7%
1/6 • Number of events 1
|
66.7%
6/9 • Number of events 6
|
100.0%
6/6 • Number of events 6
|
|
General disorders
Insomnia
|
33.3%
2/6 • Number of events 2
|
77.8%
7/9 • Number of events 7
|
66.7%
4/6 • Number of events 4
|
|
General disorders
Akinesia
|
33.3%
2/6 • Number of events 2
|
55.6%
5/9 • Number of events 5
|
83.3%
5/6 • Number of events 5
|
|
General disorders
Hypersomnia
|
33.3%
2/6 • Number of events 2
|
44.4%
4/9 • Number of events 4
|
66.7%
4/6 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
50.0%
3/6 • Number of events 3
|
33.3%
3/9 • Number of events 3
|
50.0%
3/6 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1
|
44.4%
4/9 • Number of events 4
|
66.7%
4/6 • Number of events 4
|
|
Cardiac disorders
Orthostatic faintness
|
16.7%
1/6 • Number of events 1
|
33.3%
3/9 • Number of events 3
|
66.7%
4/6 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2
|
33.3%
3/9 • Number of events 3
|
50.0%
3/6 • Number of events 3
|
|
Reproductive system and breast disorders
Decreased sex drive
|
16.7%
1/6 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
66.7%
4/6 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
16.7%
1/6 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
66.7%
4/6 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6
|
33.3%
3/9 • Number of events 3
|
50.0%
3/6 • Number of events 3
|
|
Reproductive system and breast disorders
Diminished sexual arousal
|
16.7%
1/6 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
50.0%
3/6 • Number of events 3
|
|
Gastrointestinal disorders
sialorrhea
|
16.7%
1/6 • Number of events 1
|
33.3%
3/9 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
|
Renal and urinary disorders
Urinary hesitancy
|
16.7%
1/6 • Number of events 1
|
33.3%
3/9 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
|
Reproductive system and breast disorders
Gynecomastia/galactorrhea/
|
16.7%
1/6 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
|
Reproductive system and breast disorders
Menstrual irregularities
|
16.7%
1/6 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
|
Reproductive system and breast disorders
Problem with sexual orgasm
|
16.7%
1/6 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
|
Renal and urinary disorders
Incontinence/nocturia
|
0.00%
0/6
|
0.00%
0/9
|
33.3%
2/6 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place