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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jack Cornelius, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00149643
First received: September 6, 2005
Last updated: June 17, 2013
Last verified: June 2013
Results First Received: February 8, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Depressive Disorder, Major
Cannabis Abuse
Interventions: Drug: Fluoxetine
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Fluoxetine     Placebo  
STARTED     34     36  
COMPLETED     0     0  
NOT COMPLETED     34     36  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    Fluoxetine     Placebo     Total  
Number of Participants  
[units: participants]
  34     36     70  
Age  
[units: participants]
     
<=18 years     2     2     4  
Between 18 and 65 years     32     34     66  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  21.1  ± 2.4     21.1  ± 2.4     21.1  ± 2.4  
Gender  
[units: participants]
     
Female     14     12     26  
Male     20     24     44  
Region of Enrollment  
[units: participants]
     
United States     34     36     70  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Days Per Week of Cannabis Use.   [ Time Frame: 12 Weeks ]

2.  Primary:   Depression Symptoms at Week 12   [ Time Frame: 12 Weeks ]

3.  Secondary:   Number of Cannabis Use Disorder Criterion Met at a Particular Time Point.   [ Time Frame: 12 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: corneliusjr@upmc.edu


Publications of Results:

Responsible Party: Jack Cornelius, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00149643     History of Changes
Other Study ID Numbers: NIDA-19142-1, R01DA019142, DPMC
Study First Received: September 6, 2005
Results First Received: February 8, 2012
Last Updated: June 17, 2013
Health Authority: United States: Federal Government