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Trial record 53 of 450 for:    QUETIAPINE

Efficacy Study of Quetiapine Plus Topiramate for Reducing Cannabis Consumption and Bipolar Mania

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ClinicalTrials.gov Identifier: NCT00393978
Recruitment Status : Completed
First Posted : October 31, 2006
Results First Posted : August 29, 2017
Last Update Posted : September 26, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Melissa Delbello, University of Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Bipolar Disorder
Cannabis-Related Disorder
Interventions Drug: Quetiapine and placebo
Drug: Quetiapine and Topiramate
Enrollment 75
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Quitiapine + Placebo Quetiapine + Topiramate
Hide Arm/Group Description

Quetiapine + Placebo

quetiapine + placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).

Quetiapine + Topiramate

Quetiapine + Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).

Period Title: Overall Study
Started 37 38
Completed 21 18
Not Completed 16 20
Arm/Group Title Quitiapine + Placebo Quetiapine + Topiramate Total
Hide Arm/Group Description

Quetiapine + Placebo

quetiapine + placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).

Quetiapine + Topiramate

Quetiapine + Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).

Total of all reporting groups
Overall Number of Baseline Participants 37 38 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
<=18 years
37
 100.0%
38
 100.0%
75
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 38 participants 75 participants
17.1  (2.1) 17.7  (2.1) 17.4  (0.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
Female
18
  48.6%
20
  52.6%
38
  50.7%
Male
19
  51.4%
18
  47.4%
37
  49.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants 38 participants 75 participants
37 38 75
1.Primary Outcome
Title Change in Joints Per Week
Hide Description Change in timeline follow-back self-reported of joint equivalents per week from baseline to 16 weeks.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quitiapine and Placebo Quetiapine and Topiramate
Hide Arm/Group Description:

Quetiapine and Placebo

Quetiapine and placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).

Quetiapine and Topiramate

Quetiapine and Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).

Overall Number of Participants Analyzed 37 38
Mean (Standard Deviation)
Unit of Measure: joints
-10.1  (27.2) -10.7  (18.4)
2.Primary Outcome
Title Change in Percent Days of Cannabis Use Per Week
Hide Description Change in percent days of cannabis use per week from baseline to week 16.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quitiapine and Placebo Quetiapine and Topiramate
Hide Arm/Group Description:

Quetiapine and Placebo

Quetiapine and placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).

Quetiapine and Topiramate

Quetiapine and Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).

Overall Number of Participants Analyzed 37 38
Mean (Standard Deviation)
Unit of Measure: cannabis use
-29.9  (41.1) -43.5  (38.1)
Time Frame Over a period of 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quitiapine + Placebo Quetiapine + Topiramate
Hide Arm/Group Description

Quetiapine + Placebo

quetiapine + placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).

Quetiapine + Topiramate

Quetiapine + Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).

All-Cause Mortality
Quitiapine + Placebo Quetiapine + Topiramate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Quitiapine + Placebo Quetiapine + Topiramate
Affected / at Risk (%) Affected / at Risk (%)
Total   6/37 (16.22%)   5/38 (13.16%) 
Psychiatric disorders     
Hospitalization  [1]  5/37 (13.51%)  4/38 (10.53%) 
Increased Suicidal Ideation  [2]  0/37 (0.00%)  1/38 (2.63%) 
Reproductive system and breast disorders     
Pregnancy   1/37 (2.70%)  0/38 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Exacerbation of illness
[2]
Increased suicidal ideation during hospitalization
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quitiapine + Placebo Quetiapine + Topiramate
Affected / at Risk (%) Affected / at Risk (%)
Total   30/37 (81.08%)   23/38 (60.53%) 
General disorders     
Difficulty falling asleep   20/37 (54.05%)  12/38 (31.58%) 
Difficulty staying asleep   20/37 (54.05%)  12/38 (31.58%) 
Excitement   0/37 (0.00%)  5/38 (13.16%) 
Dry Mouth   30/37 (81.08%)  23/38 (60.53%) 
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Melissa P. DelBello, MD
Organization: University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience
Phone: 513-558-2989
EMail: Melissa.DelBello@uc.edu
Layout table for additonal information
Responsible Party: Melissa Delbello, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00393978     History of Changes
Other Study ID Numbers: NIDA
R01DA022221 ( U.S. NIH Grant/Contract )
First Submitted: October 30, 2006
First Posted: October 31, 2006
Results First Submitted: May 16, 2016
Results First Posted: August 29, 2017
Last Update Posted: September 26, 2017