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Trial record 92 of 450 for:    QUETIAPINE

Efficacy and Tolerability of Topiramate in Treatment of Bipolar Mania and Alcohol Use in Adolescents and Young Adults

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.
 
ClinicalTrials.gov Identifier: NCT00550394
Recruitment Status : Completed
First Posted : October 29, 2007
Results First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Melissa Delbello, University of Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Bipolar Disorder
Alcohol Abuse
Interventions Drug: quetiapine and placebo
Drug: Quetiapine and Topiramate
Enrollment 56
Recruitment Details 56 study participants were consented for study participation, of which 17 were screen fails.
Pre-assignment Details 56 study participants were consented for study participation, of which 17 were screen fails.
Arm/Group Title Quetiapine and Placebo Quetiapine and Topiramate
Hide Arm/Group Description

Quetiapine and Placebo

quetiapine and placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1

Dosing Schedule and Titration of Topiramate:

All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.

Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4.

Quetiapine and Topiramate

Quetiapine and Topiramate: Dosing Schedule and Titration of Quetiapine:

open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1

Dosing Schedule and Titration of Topiramate:

All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.

Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4.

Period Title: Overall Study
Started 21 18
Completed 9 5
Not Completed 12 13
Arm/Group Title Quitiapine and Placebo Quitiapine andTopiramate Total
Hide Arm/Group Description

Quetiapine and Placebo

quetiapine and placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1

Dosing Schedule and Titration of Topiramate:

All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.

Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4.

Quetiapine and Topiramate

Quetiapine andTopiramate: Dosing Schedule and Titration of Quetiapine:

open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1

Dosing Schedule and Titration of Topiramate:

All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.

Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4.

Total of all reporting groups
Overall Number of Baseline Participants 21 18 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 18 participants 39 participants
<=18 years
21
 100.0%
18
 100.0%
39
 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 21 participants 18 participants 39 participants
18  (3.1) 17.7  (2.4) 17.9  (2.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 18 participants 39 participants
Female
16
  76.2%
8
  44.4%
24
  61.5%
Male
5
  23.8%
10
  55.6%
15
  38.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 18 participants 39 participants
21 18 39
1.Primary Outcome
Title Drinks Per Day
Hide Description Change in self-reported drinks/day (drinks consumed divided by the number of days during that study period).
Time Frame baseline to 12 weeks or endpoint (up to 11 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine + Placebo Quetiapine + Topiramate
Hide Arm/Group Description:

Quetiapine + Placebo

quetiapine + placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1

Dosing Schedule and Titration of Topiramate:

All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.

Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4.

Quetiapine + Topiramate

Quetiapine + Topiramate: Dosing Schedule and Titration of Quetiapine:

open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1

Dosing Schedule and Titration of Topiramate:

All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.

Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4.

Overall Number of Participants Analyzed 21 18
Mean (Standard Deviation)
Unit of Measure: Drinks per day
-1.4  (2.3) -2.4  (5.1)
2.Primary Outcome
Title Drinks Per Drinking Day
Hide Description Change in drinks/drinking day (number of drinks consumed divided by the number of days during which alcohol was consumed during that study period)
Time Frame baseline to 12 weeks or endpoint (up to 11 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine and Placebo Quetiapine and Topiramate
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Quetiapine and Placebo
Quetiapine and Topiramate
Overall Number of Participants Analyzed 21 18
Mean (Standard Deviation)
Unit of Measure: Drinks per drinking day
-7.2  (10.2) -7.3  (6.0)
3.Primary Outcome
Title Percentage of Days Abstinent
Hide Description Change in percent days abstinent (the number of non-drinking days divided by the number of days in that study period).
Time Frame baseline to 12 weeks or endpoint (up to 11 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine and Placebo Quetiapine and Topiramate
Hide Arm/Group Description:
Quetiapine and Placebo
Quetiapine and Topiramate
Overall Number of Participants Analyzed 21 18
Mean (Standard Deviation)
Unit of Measure: Percentage of days abstinent
15  (19) 14  (23)
4.Primary Outcome
Title Percent Heavy Drinking Days
Hide Description Change in percent heavy drinking days (number of days of > 4 drinks/day divided by number of days in that study period).
Time Frame baseline to 12 weeks or endpoint (up to 11 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine and Placebo Quetiapine and Topiramate
Hide Arm/Group Description:
Quetiapine and Placebo
Quetiapine and Topiramate
Overall Number of Participants Analyzed 21 18
Mean (Standard Deviation)
Unit of Measure: Percent heavy drinking days
-10  (19) -14  (25)
Time Frame 3 years 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine and Placebo Quetiapine and Topiramate
Hide Arm/Group Description

Quetiapine and Placebo

quetiapine + placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1

Dosing Schedule and Titration of Topiramate:

All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.

Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4.

Quetiapine and Topiramate

Quetiapine + Topiramate: Dosing Schedule and Titration of Quetiapine:

open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1

Dosing Schedule and Titration of Topiramate:

All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.

Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4.

All-Cause Mortality
Quetiapine and Placebo Quetiapine and Topiramate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine and Placebo Quetiapine and Topiramate
Affected / at Risk (%) Affected / at Risk (%)
Total   8/21 (38.10%)   2/18 (11.11%) 
General disorders     
Suicidal ideation   7/21 (33.33%)  2/18 (11.11%) 
Suicide Attempt   1/21 (4.76%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine and Placebo Quetiapine and Topiramate
Affected / at Risk (%) Affected / at Risk (%)
Total   4/21 (19.05%)   11/18 (61.11%) 
General disorders     
sedation   4/21 (19.05%)  11/18 (61.11%) 
Difficulty Arousing   3/21 (14.29%)  9/18 (50.00%) 
Indicates events were collected by systematic assessment
Additional studies are needed as topiramate has not been systematically assessed. This study was to collect pilot data and more data will need to be collected.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Melissa DelBello, MD, MS
Organization: University of Cincinnati
Phone: 513-558-2989
EMail: delbelmp@uc.edu
Layout table for additonal information
Responsible Party: Melissa Delbello, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00550394     History of Changes
Other Study ID Numbers: NIAAA
R21AA016372 ( U.S. NIH Grant/Contract )
First Submitted: October 25, 2007
First Posted: October 29, 2007
Results First Submitted: May 19, 2016
Results First Posted: May 23, 2017
Last Update Posted: May 23, 2017