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Trial record 42 of 450 for:    QUETIAPINE

A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency

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: NCT01165541
Recruitment Status : Completed
First Posted : July 20, 2010
Results First Posted : March 31, 2014
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Alan Green, Dartmouth-Hitchcock Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Alcohol Dependence
Interventions Drug: Mirtazapine
Drug: Quetiapine fumarate extended release (Quetiapine XR)
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Entire Study Population
Hide Arm/Group Description Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d first for 7 weeks; then Quetiapine XR plus mirtazapine: Quetiapine fumarate extended release (50-400mg) plus mirtazapine (7.5-45mg) for 7 weeks.
Period Title: Quetiapine XR Monotherapy
Started 20
Completed 16
Not Completed 4
Period Title: Quetiapine XR and Mirtazepine
Started 16
Completed 11
Not Completed 5
Arm/Group Title Entire Study Population
Hide Arm/Group Description Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d first for 7 weeks; then Quetiapine XR and mirtazapine: Quetiapine fumarate extended release (50-400mg) and mirtazapine (7.5-45mg) for 7 weeks.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
Entire study population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
48.1  (10.1)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
6
  30.0%
Male
14
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Number of Very Heavy Drinking Days Per Week
Hide Description The number of “very heavy” drinking days (8 or more drinks per drinking day for men or 6 or more drinks per drinking day for women) per week
Time Frame 14 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population only consists of participants that completed both phases of the study.
Arm/Group Title Quetiapine Fumarate Extended Release (Quetiapine XR) Quetiapine XR Plus Mirtazapine
Hide Arm/Group Description:

Quetiapine XR 50-400mg

Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d

Quetiapine XR 50-400mg + Mirtazapine 7.5-45mg

Quetiapine XR plus mirtazapine: Quetiapine fumarate extended release (50-400mg) plus mirtazapine (7.5-45mg)

Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: days
2.1  (2.8) 1.3  (2.4)
Time Frame Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events..
Adverse Event Reporting Description This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
 
Arm/Group Title Quetiapine Fumarate Extended Release (Quetiapine XR) Quetiapine XR andMirtazapine
Hide Arm/Group Description

Quetiapine XR 50-400mg

Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d

Quetiapine XR 50-400mg + Mirtazapine 7.5-45mg

Quetiapine XR and mirtazapine: Quetiapine fumarate extended release (50-400mg) and mirtazapine (7.5-45mg)

All-Cause Mortality
Quetiapine Fumarate Extended Release (Quetiapine XR) Quetiapine XR andMirtazapine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine Fumarate Extended Release (Quetiapine XR) Quetiapine XR andMirtazapine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine Fumarate Extended Release (Quetiapine XR) Quetiapine XR andMirtazapine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/20 (100.00%)      14/16 (87.50%)    
Cardiac disorders     
Prolonged QTC *  0/20 (0.00%)  0 1/16 (6.25%)  1
Eye disorders     
Blurred Vision *  1/20 (5.00%)  1 0/16 (0.00%)  0
Gastrointestinal disorders     
Dry Mouth *  7/20 (35.00%)  7 2/16 (12.50%)  2
Gastrointestinal Problems *  9/20 (45.00%)  12 4/16 (25.00%)  7
General disorders     
Fatigue *  5/20 (25.00%)  6 3/16 (18.75%)  4
Foggy Thinking *  3/20 (15.00%)  4 3/16 (18.75%)  4
Sweats *  1/20 (5.00%)  1 2/16 (12.50%)  2
Fever *  1/20 (5.00%)  1 0/16 (0.00%)  0
Swelling *  1/20 (5.00%)  2 0/16 (0.00%)  0
Injury, poisoning and procedural complications     
Injury *  2/20 (10.00%)  5 1/16 (6.25%)  1
Investigations     
Increase Triglycerides *  0/20 (0.00%)  0 2/16 (12.50%)  2
Metabolism and nutrition disorders     
Weight Gain *  1/20 (5.00%)  1 2/16 (12.50%)  2
Appetite Increased *  1/20 (5.00%)  1 0/16 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscoloskeletal Disorder *  3/20 (15.00%)  4 7/16 (43.75%)  10
Nervous system disorders     
Dizzy *  6/20 (30.00%)  6 1/16 (6.25%)  1
Headache *  4/20 (20.00%)  4 3/16 (18.75%)  4
Insomnia *  3/20 (15.00%)  4 2/16 (12.50%)  3
Neurologic Disorder *  4/20 (20.00%)  5 3/16 (18.75%)  3
Somnolence *  8/20 (40.00%)  9 6/16 (37.50%)  6
Psychiatric disorders     
Unusual Dream Activity *  3/20 (15.00%)  3 1/16 (6.25%)  1
Irritated *  2/20 (10.00%)  2 1/16 (6.25%)  1
Miscellaneous Sleep Disorder *  2/20 (10.00%)  2 1/16 (6.25%)  1
Psychiatric Symptoms *  2/20 (10.00%)  4 2/16 (12.50%)  2
Libido Descreased *  1/20 (5.00%)  1 0/16 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Nose Bleeds *  2/20 (10.00%)  3 0/16 (0.00%)  0
Upper Respiratory Symptoms *  3/20 (15.00%)  6 0/16 (0.00%)  0
Decreased Smoking *  1/20 (5.00%)  1 0/16 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatological Condition *  2/20 (10.00%)  2 1/16 (6.25%)  1
*
Indicates events were collected by non-systematic assessment
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: Mary Brunette, MD
Organization: Geisel School of Medicine At Dartmouth
Phone: 603-271-7642
EMail: mary.brunette@dartmouth.edu
Layout table for additonal information
Responsible Party: Alan Green, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01165541     History of Changes
Other Study ID Numbers: QM1
First Submitted: July 16, 2010
First Posted: July 20, 2010
Results First Submitted: December 19, 2013
Results First Posted: March 31, 2014
Last Update Posted: April 9, 2018