We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00149643
First Posted: September 8, 2005
Last Update Posted: June 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Jack Cornelius, University of Pittsburgh
Results First Submitted: February 8, 2012  
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

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 ( 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