Trial Outcomes & Findings for First Episode Schizophrenia and Cannabis-Related Disorder Study (NCT NCT00573287)

Last Updated: 2019-07-23

Results Overview

Based on the small sample size, it was not possible to test the differences between the two groups for statistical significance. Data on cannabis use were gathered weekly using the Timeline Follow-back (TLFB) method. At the end of the study, graphs were plotted showing days of cannabis use per week and rated as "Improved," "Unchanged," or "Worse" by a pair of expert judges. Raters were instructed to rate the graph "Improved" or "Worsened" if it appeared to be \>20% better or worse and to rate it "Unchanged" if there was little or no change (less than \~20%).

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

24 weeks

Results posted on

2019-07-23

Participant Flow

Recruitment was conducted through Dartmouth Hitchcock Medical Center, the state psychiatric hospital, local community mental health centers and mailing to schools and primary care providers.

Participant milestones

Participant milestones
Measure	Clozapine clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks	Risperidone risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
Overall Study STARTED	7	7
Overall Study COMPLETED	3	4
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

First Episode Schizophrenia and Cannabis-Related Disorder Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clozapine n=7 Participants clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks	Risperidone n=7 Participants risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 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	22.9 years STANDARD_DEVIATION 5.8 • n=5 Participants	22.0 years STANDARD_DEVIATION 6.4 • n=7 Participants	22.4 years STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Analysis was conducted for participants who were randomized to study medication condition and actually began treatment with study drug and had a follow-up visit. Two patients (one in the Clozapine group and one in the Risperidone group) did not meet this criteria and were not included in the analysis.

Outcome measures

Outcome measures
Measure	Clozapine n=6 Participants clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks	Risperidone n=6 Participants risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
Number of Participants Demonstrating Improvement in Substance Use	3 participants	3 participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Analysis was conducted for participants who were randomized to study medication condition and actually began treatment with study drug and had follow-up visits through week two. Three patients (two in the Clozapine group and one in the Risperidone group) did not meet this criteria and were not included in the analysis.

Based on the small sample size, it was not possible to test the differences between the two groups for statistical significance. Data on psychiatric symptoms were gathered using Brief Psychiatric Rating Scale (BPRS; weekly), Clinical Global Impressions Scale (CGIS; weekly) and Schedule for the Assessment of Negative Symptoms (SANS; bi-weekly). At the end of the study, graphs were plotted showing severity of symptoms and rated as "Improved," "Unchanged," or "Worse" by a pair of expert judges. Raters were instructed to rate the graph "Improved" or "Worsened" if it appeared to be \>20% better or worse and to rate it "Unchanged" if there was little or no change (less than \~20%).

Outcome measures

Outcome measures
Measure	Clozapine n=5 Participants clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks	Risperidone n=6 Participants risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
Number of Participants Demonstrating Improvement in Psychiatric Symptoms Using the BPRS, CGIS, and SANS at 24 Weeks BPRS	4 participants	3 participants
Number of Participants Demonstrating Improvement in Psychiatric Symptoms Using the BPRS, CGIS, and SANS at 24 Weeks SANS	4 participants	2 participants
Number of Participants Demonstrating Improvement in Psychiatric Symptoms Using the BPRS, CGIS, and SANS at 24 Weeks CGIS	1 participants	2 participants

Adverse Events

Clozapine

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Risperidone

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Clozapine n=7 participants at risk clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks	Risperidone n=7 participants at risk risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
Psychiatric disorders Psychosis	42.9% 3/7 • Number of events 3 • For the 24 weeks of the study plus 30 days after the final visit.	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.

Other adverse events

Additional Information

Alan I. Green, M.D.

Geisel School of Medicine at Dartmouth

Phone: 6036507549

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Clozapine n=7 participants at risk clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks	Risperidone n=7 participants at risk risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
Cardiac disorders PALPITATIONS	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.	14.3% 1/7 • Number of events 1 • For the 24 weeks of the study plus 30 days after the final visit.
Ear and labyrinth disorders EAR AND LABYRINTH DISORDER OTHER: EAR CANAL BLOCKAGE	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.	14.3% 1/7 • Number of events 1 • For the 24 weeks of the study plus 30 days after the final visit.
General disorders FATIGUE	14.3% 1/7 • Number of events 1 • For the 24 weeks of the study plus 30 days after the final visit.	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.	14.3% 1/7 • Number of events 1 • For the 24 weeks of the study plus 30 days after the final visit.
Gastrointestinal disorders GASTOINTESTINAL DISORDERS - OTHER, SPECIFY: HYPERSALIVATION	57.1% 4/7 • Number of events 5 • For the 24 weeks of the study plus 30 days after the final visit.	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.
Injury, poisoning and procedural complications INJURY, POISONING AND PROCEDURAL COMPLICATIONS, OTHER: SPRAIN	14.3% 1/7 • Number of events 1 • For the 24 weeks of the study plus 30 days after the final visit.	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.
Investigations INVESTIGATIONS OTHER - INCREASED LIVER FUNCTION TESTS	14.3% 1/7 • Number of events 1 • For the 24 weeks of the study plus 30 days after the final visit.	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.
Investigations WEIGHT GAIN	28.6% 2/7 • Number of events 2 • For the 24 weeks of the study plus 30 days after the final visit.	28.6% 2/7 • Number of events 2 • For the 24 weeks of the study plus 30 days after the final visit.
Metabolism and nutrition disorders METABOLISM & NUTRITION DISORDERS, OTHER: INCREASED APPETITE	14.3% 1/7 • Number of events 1 • For the 24 weeks of the study plus 30 days after the final visit.	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.
Musculoskeletal and connective tissue disorders MUSCULO-SKELETAL CONNECTIVE TISSUE DISORDER-OTHER, MUSCLE TWITCH	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.	14.3% 1/7 • Number of events 1 • For the 24 weeks of the study plus 30 days after the final visit.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL OTHER: ANKLE PAIN	14.3% 1/7 • Number of events 1 • For the 24 weeks of the study plus 30 days after the final visit.	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL OTHER: KNEE AND FOOT PAIN	14.3% 1/7 • Number of events 1 • For the 24 weeks of the study plus 30 days after the final visit.	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.
Nervous system disorders AKATHISIA	14.3% 1/7 • Number of events 1 • For the 24 weeks of the study plus 30 days after the final visit.	14.3% 1/7 • Number of events 2 • For the 24 weeks of the study plus 30 days after the final visit.
Nervous system disorders EXTRAPYRAMIDAL DISORDER	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.	14.3% 1/7 • Number of events 1 • For the 24 weeks of the study plus 30 days after the final visit.
Nervous system disorders HEADACHE	28.6% 2/7 • Number of events 2 • For the 24 weeks of the study plus 30 days after the final visit.	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.
Nervous system disorders SOMNOLENCE	71.4% 5/7 • Number of events 8 • For the 24 weeks of the study plus 30 days after the final visit.	14.3% 1/7 • Number of events 1 • For the 24 weeks of the study plus 30 days after the final visit.
Psychiatric disorders ANXIETY	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.	14.3% 1/7 • Number of events 1 • For the 24 weeks of the study plus 30 days after the final visit.
Psychiatric disorders DECREASED LIBIDO	14.3% 1/7 • Number of events 1 • For the 24 weeks of the study plus 30 days after the final visit.	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.
Renal and urinary disorders URINARY RETENTION	14.3% 1/7 • Number of events 1 • For the 24 weeks of the study plus 30 days after the final visit.	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.
Renal and urinary disorders URINARY UREGENCY	14.3% 1/7 • Number of events 1 • For the 24 weeks of the study plus 30 days after the final visit.	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS, OTHER: ACNE	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.	14.3% 1/7 • Number of events 1 • For the 24 weeks of the study plus 30 days after the final visit.
Vascular disorders HYPOTENSION	14.3% 1/7 • Number of events 1 • For the 24 weeks of the study plus 30 days after the final visit.	0.00% 0/7 • For the 24 weeks of the study plus 30 days after the final visit.