Trial Outcomes & Findings for Treatment of Schizophrenia and Comorbid Cannabis Use Disorder: Comparing Clozapine to Treatment-as-Usual (NCT NCT00498550)
NCT ID: NCT00498550
Last Updated: 2019-03-13
Results Overview
Intensity of cannabis use is obtained for each week retrospectively as the number of joints smoked during the prior week (assessed by the Timeline Followback Scale). Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
31 participants
Primary outcome timeframe
Week 1 to week 12
Results posted on
2019-03-13
Participant Flow
Participant milestones
| Measure |
Clozapine
Clozapine, Clozaril
|
Treatment as Usual
Treatment as usual with any antipsychotic other than Clozapine.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Schizophrenia and Comorbid Cannabis Use Disorder: Comparing Clozapine to Treatment-as-Usual
Baseline characteristics by cohort
| Measure |
Clozapine
n=15 Participants
Clozapine, Clozaril
|
Treatment as Usual
n=16 Participants
Treatment as usual with any antipsychotic other than Clozapine.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
39.0 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
36 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 1 to week 12Intensity of cannabis use is obtained for each week retrospectively as the number of joints smoked during the prior week (assessed by the Timeline Followback Scale). Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number.
Outcome measures
| Measure |
Clozapine
n=15 Participants
Clozapine, Clozaril
|
Treatment as Usual
n=16 Participants
Treatment as usual with any antipsychotic other than Clozapine.
|
|---|---|---|
|
Average Over Time of Intensity of Cannabis Use (Used to Evaluate Treatment Efficacy)
|
0.02 Joints per week
Interval -2.1 to 2.5
|
4.56 Joints per week
Interval -0.2 to 9.3
|
Adverse Events
Clozapine
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Treatment as Usual
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clozapine
n=15 participants at risk
Clozapine, Clozaril
|
Treatment as Usual
n=16 participants at risk
Treatment as usual with any antipsychotic other than Clozapine.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • 12 Weeks
|
0.00%
0/16 • 12 Weeks
|
|
Psychiatric disorders
Psychiatric Disorder - Other: Accidental Overdose
|
0.00%
0/15 • 12 Weeks
|
6.2%
1/16 • Number of events 1 • 12 Weeks
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/15 • 12 Weeks
|
6.2%
1/16 • Number of events 1 • 12 Weeks
|
|
Psychiatric disorders
Suicide Attempt
|
6.7%
1/15 • Number of events 1 • 12 Weeks
|
6.2%
1/16 • Number of events 2 • 12 Weeks
|
|
Psychiatric disorders
Depression
|
6.7%
1/15 • Number of events 1 • 12 Weeks
|
0.00%
0/16 • 12 Weeks
|
|
Psychiatric disorders
Psychosis
|
6.7%
1/15 • Number of events 1 • 12 Weeks
|
0.00%
0/16 • 12 Weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/15 • 12 Weeks
|
6.2%
1/16 • Number of events 2 • 12 Weeks
|
Other adverse events
| Measure |
Clozapine
n=15 participants at risk
Clozapine, Clozaril
|
Treatment as Usual
n=16 participants at risk
Treatment as usual with any antipsychotic other than Clozapine.
|
|---|---|---|
|
Psychiatric disorders
Agitation
|
6.7%
1/15 • Number of events 1 • 12 Weeks
|
6.2%
1/16 • Number of events 1 • 12 Weeks
|
|
Nervous system disorders
Akathisia
|
6.7%
1/15 • Number of events 1 • 12 Weeks
|
6.2%
1/16 • Number of events 1 • 12 Weeks
|
|
Gastrointestinal disorders
Constipation
|
26.7%
4/15 • Number of events 4 • 12 Weeks
|
0.00%
0/16 • 12 Weeks
|
|
Psychiatric disorders
Depression
|
6.7%
1/15 • Number of events 1 • 12 Weeks
|
6.2%
1/16 • Number of events 1 • 12 Weeks
|
|
Nervous system disorders
Dizziness
|
33.3%
5/15 • Number of events 8 • 12 Weeks
|
6.2%
1/16 • Number of events 1 • 12 Weeks
|
|
Gastrointestinal disorders
Dry Mouth
|
13.3%
2/15 • Number of events 3 • 12 Weeks
|
12.5%
2/16 • Number of events 2 • 12 Weeks
|
|
General disorders
Fatigue
|
20.0%
3/15 • Number of events 3 • 12 Weeks
|
0.00%
0/16 • 12 Weeks
|
|
General disorders
Flu Like Symptoms
|
0.00%
0/15 • 12 Weeks
|
12.5%
2/16 • Number of events 2 • 12 Weeks
|
|
Gastrointestinal disorders
Gastrointestinal Disorder - Other: Hypersalivation
|
66.7%
10/15 • Number of events 11 • 12 Weeks
|
0.00%
0/16 • 12 Weeks
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 3 • 12 Weeks
|
6.2%
1/16 • Number of events 1 • 12 Weeks
|
|
Cardiac disorders
Hypertension
|
13.3%
2/15 • Number of events 2 • 12 Weeks
|
12.5%
2/16 • Number of events 2 • 12 Weeks
|
|
Psychiatric disorders
Insomnia
|
13.3%
2/15 • Number of events 2 • 12 Weeks
|
6.2%
1/16 • Number of events 1 • 12 Weeks
|
|
General disorders
Irritability
|
6.7%
1/15 • Number of events 1 • 12 Weeks
|
6.2%
1/16 • Number of events 1 • 12 Weeks
|
|
Reproductive system and breast disorders
Libido Decreased
|
6.7%
1/15 • Number of events 1 • 12 Weeks
|
6.2%
1/16 • Number of events 1 • 12 Weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorder - Other: Muscle Spasms
|
13.3%
2/15 • Number of events 2 • 12 Weeks
|
0.00%
0/16 • 12 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/15 • 12 Weeks
|
12.5%
2/16 • Number of events 3 • 12 Weeks
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 5 • 12 Weeks
|
6.2%
1/16 • Number of events 1 • 12 Weeks
|
|
Nervous system disorders
Nervous Sytem Disorder - Other: Unusual Dream Activity
|
0.00%
0/15 • 12 Weeks
|
12.5%
2/16 • Number of events 2 • 12 Weeks
|
|
General disorders
Non-Cardiac Chest Pain
|
6.7%
1/15 • Number of events 1 • 12 Weeks
|
6.2%
1/16 • Number of events 1 • 12 Weeks
|
|
Nervous system disorders
Somnolence
|
60.0%
9/15 • Number of events 12 • 12 Weeks
|
12.5%
2/16 • Number of events 2 • 12 Weeks
|
|
Renal and urinary disorders
Urinary Incontinence
|
13.3%
2/15 • Number of events 2 • 12 Weeks
|
0.00%
0/16 • 12 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 2 • 12 Weeks
|
18.8%
3/16 • Number of events 3 • 12 Weeks
|
|
Investigations
Weight Gain
|
40.0%
6/15 • Number of events 7 • 12 Weeks
|
12.5%
2/16 • Number of events 3 • 12 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place