Trial Outcomes & Findings for Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence (NCT NCT00149643)

Results Overview

The number days out of the last seven days that cannabis was used.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

70 participants

Primary outcome timeframe

12 Weeks

Results posted on

2013-06-24

Participant Flow

This study was conducted at the Western Psychiatric Institute and Clinic (WPIC) of the University of Pittsburgh Medical Center (UPMC). Subjects were recruited for participation in the treatment study through referrals from any of the WPIC treatment programs and by responding to newspaper, radio, and bus advertisements.

Participant milestones

Participant milestones
Measure	Fluoxetine Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.	Placebo Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
Overall Study STARTED	34	36
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	34	36

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluoxetine n=34 Participants Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.	Placebo n=36 Participants Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.	Total n=70 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	32 Participants n=5 Participants	34 Participants n=7 Participants	66 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	21.1 years STANDARD_DEVIATION 2.4 • n=5 Participants	21.1 years STANDARD_DEVIATION 2.4 • n=7 Participants	21.1 years STANDARD_DEVIATION 2.4 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	24 Participants n=7 Participants	44 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	36 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Weeks

The number days out of the last seven days that cannabis was used.

Outcome measures

Outcome measures
Measure	Fluoxetine n=34 Participants Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.	Placebo n=36 Participants Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
Days Per Week of Cannabis Use.	3.88 Days of cannabis use per week Standard Deviation 2.6	3.1 Days of cannabis use per week Standard Deviation 2.27

PRIMARY outcome

Timeframe: 12 Weeks

Average of Beck Depression Inventory (BDI) Scores measured at Weeks 1-4, 6, 8, 10 and 12. The BDI is a subject reported measure that has a minimim score of 0 and a maximum score of 63. A better outcome would consist of values near the minimum end of the scale (0) and a worse outcome would consist of values near the maximum end of the scare (63). Each DSM-IV criteron asses a different depressive symptom.

Outcome measures

Outcome measures
Measure	Fluoxetine n=34 Participants Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.	Placebo n=36 Participants Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
Depression Symptoms at Week 12	7.79 BDI Total Standard Deviation 8.29	7.31 BDI Total Standard Deviation 7.98

SECONDARY outcome

Timeframe: 12 Weeks

Criterion used in this study was the number of DSM-IV cannabis use disorder symptoms (criteria) that were met.

Outcome measures

Outcome measures
Measure	Fluoxetine n=34 Participants Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.	Placebo n=36 Participants Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
Number of Cannabis Use Disorder Criterion Met at a Particular Time Point.	0.59 Number of DSM-IV criterion Standard Deviation 0.79	0.47 Number of DSM-IV criterion Standard Deviation 0.65

Adverse Events

Fluoxetine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jack R. Cornelius, M.D.

University of Pittsburgh

Phone: 412-246-6906

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place