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

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ClinicalTrials.gov Identifier: NCT00149643
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : September 3, 2012
Last Update Posted : June 24, 2013
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Jack Cornelius, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Depressive Disorder, Major
Cannabis Abuse
Interventions Drug: Fluoxetine
Other: Placebo
Enrollment 70

Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Fluoxetine Placebo
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 34 36
Completed 0 0
Not Completed 34 36
Arm/Group Title Fluoxetine Placebo Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 34 36 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 36 participants 70 participants
<=18 years
2
   5.9%
2
   5.6%
4
   5.7%
Between 18 and 65 years
32
  94.1%
34
  94.4%
66
  94.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 36 participants 70 participants
21.1  (2.4) 21.1  (2.4) 21.1  (2.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 36 participants 70 participants
Female
14
  41.2%
12
  33.3%
26
  37.1%
Male
20
  58.8%
24
  66.7%
44
  62.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 36 participants 70 participants
34 36 70
1.Primary Outcome
Title Days Per Week of Cannabis Use.
Hide Description The number days out of the last seven days that cannabis was used.
Time Frame 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoxetine Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 34 36
Mean (Standard Deviation)
Unit of Measure: Days of cannabis use per week
3.88  (2.6) 3.1  (2.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments Groups’ categorical baseline measures were compared by chi-square analysis, corrected for continuity. Statistical analyses were completed on an intent to-treat study group basis. Outcome measures for depression and for cannabis use and alcohol use across treatment groups were compared by repeated measures analysis of variance. The last observation carried forward (LOCF)method was used for handling missing data in the data analyses.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Depression Symptoms at Week 12
Hide Description 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.
Time Frame 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoxetine Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 34 36
Mean (Standard Deviation)
Unit of Measure: BDI Total
7.79  (8.29) 7.31  (7.98)
3.Secondary Outcome
Title Number of Cannabis Use Disorder Criterion Met at a Particular Time Point.
Hide Description Criterion used in this study was the number of DSM-IV cannabis use disorder symptoms (criteria) that were met.
Time Frame 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoxetine Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 34 36
Mean (Standard Deviation)
Unit of Measure: Number of DSM-IV criterion
0.59  (0.79) 0.47  (0.65)
Time Frame Adverse events were tracked during the 12-week acute treatment phase.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluoxetine Placebo
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Fluoxetine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fluoxetine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/36 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Fluoxetine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/36 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jack R. Cornelius, M.D.
Organization: University of Pittsburgh
Phone: 412-246-6906
Responsible Party: Jack Cornelius, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00149643     History of Changes
Other Study ID Numbers: NIDA-19142-1
R01DA019142 ( U.S. NIH Grant/Contract )
DPMC
First Submitted: September 6, 2005
First Posted: September 8, 2005
Results First Submitted: February 8, 2012
Results First Posted: September 3, 2012
Last Update Posted: June 24, 2013