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Trial record 1 of 2 for:    10653215 [PUBMED-IDS]
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Efficacy of Quetiapine in the Treatment of Patients With Schizophrenia and a Comorbid Substance Use Disorder

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ClinicalTrials.gov Identifier: NCT00156715
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : December 21, 2010
Last Update Posted : March 14, 2018
Sponsor:
Collaborators:
Augusta University
AstraZeneca
Information provided by (Responsible Party):
Alan Green, Dartmouth-Hitchcock Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Schizophrenia
Schizoaffective Disorder
Psychotic Disorder
Substance Abuse
Alcohol Abuse
Intervention Drug: Quetiapine
Enrollment 23
Recruitment Details Participants were recruited from two urban study sites, one in New England, the other in the Southeast, primarily through clinician referral, over two years. All participants gave informed consent.
Pre-assignment Details Prior to starting quetiapine, all participants first completed a screening assessment to establish diagnosis, amount of alcohol (and other drugs) consumed, and current medications and medical status. This data was used to characterize the group and assess whether they met eligibility criteria for the study.
Arm/Group Title QUET
Hide Arm/Group Description After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
Period Title: Overall Study
Started 23
Completed 16
Not Completed 7
Arm/Group Title QUET
Hide Arm/Group Description After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
<=18 years
0
   0.0%
Between 18 and 65 years
23
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
35.8  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
6
  26.1%
Male
17
  73.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
1.Primary Outcome
Title Mean Number of Drinking Days Per Week
Hide Description Timeline Follow-back (TLFB) procedure was used at screening and baseline to establish current substance use, and it was also used weekly during the course of the study to assess continued alcohol and other substance use. TLFB cosisted of using a calendar and sasking participants to report alcohol and other drug use since last visit. At the screening visit, the TLFB was done for the four weeks prior to the visit.
Time Frame 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants who received at least 4 weeks of treatment with quetiapine were included in this analysis. Site differences resulted in only the 11 participants from Site 1 to be included in the analysis. Participants from Site 2 were all admitted to the study directly from the hospital which could have affected their alcohol consumption.
Arm/Group Title QUET
Hide Arm/Group Description:
After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: Drinking Days per Week
2.7  (2.3)
2.Secondary Outcome
Title Clinical Symptoms
Hide Description The main outcome measure of clinical symptoms was the Positive and Negative Symptoms Scale. This is a 30 item scale for assessing patients diagnosed with schizophrenia. Each item is rated on a 1 (absent) to 7 (extreme) scale. The minimum total score is 30 and the maximum is 210.
Time Frame 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants who received at least 4 weeks of treatment with quetiapine were included in this analysis. Site differences resulted in only the 11 participants from Site 1 to be included in this analysis. Participants from Site 2 were all admitted to the study directly from the hospital, which could have affected their behavior.
Arm/Group Title QUET
Hide Arm/Group Description:
After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: Units on a scale
65.5  (16.5)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title QUET
Hide Arm/Group Description After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
All-Cause Mortality
QUET
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
QUET
Affected / at Risk (%) # Events
Total   3/16 (18.75%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lump in Breast  [1]  1/16 (6.25%)  1
Psychiatric disorders   
Increased Psychosis   2/16 (12.50%)  3
Suicidal Ideation/Attempt   2/16 (12.50%)  2
Respiratory, thoracic and mediastinal disorders   
Pneumonia   1/16 (6.25%)  1
Indicates events were collected by systematic assessment
[1]
Could not obtain biopsy results
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
QUET
Affected / at Risk (%) # Events
Total   13/16 (81.25%)    
Cardiac disorders   
Hypertension   2/16 (12.50%)  2
Palpatations   1/16 (6.25%)  1
Gastrointestinal disorders   
Gi Distress/Poor Appetite   2/16 (12.50%)  2
General disorders   
Dry Mouth   7/16 (43.75%)  7
Sleeplessness   4/16 (25.00%)  4
Pain   3/16 (18.75%)  3
Cold or Flu Symptoms   4/16 (25.00%)  5
Sedation   7/16 (43.75%)  9
Heaviness/Pressure   2/16 (12.50%)  2
Dizzy   3/16 (18.75%)  3
Fall   1/16 (6.25%)  1
Other   4/16 (25.00%)  7
Metabolism and nutrition disorders   
Increased Appetite/Weight Gain   5/16 (31.25%)  5
Musculoskeletal and connective tissue disorders   
Stiffness   1/16 (6.25%)  1
Psychiatric disorders   
Unusual Dream Activity   3/16 (18.75%)  3
Respiratory, thoracic and mediastinal disorders   
Shortness of Breath   1/16 (6.25%)  1
Indicates events were collected by systematic assessment
Lack of a control group; Small study group size, and the consequent lack of power to detect a significant change; Differences between the populations at the two sites.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Christopher OKeefe, M.A
Organization: Dartmouth Medical School
Phone: 603-271-5287
Publications:
Buckley PF, Naber D: Quetiapine and sertindole: clinical use and experience. In: Schizophrenia and Mood Disorders: The New Drug Therapies in Clinical Practice. Edited by PF Buckley and JL Waddington. Butterworth-Heinemann, 2000.
Buckley P, McCarthy M, Chapman P, Richman C, Yamamoto B. Clozapine treatment of comorbid substance abuse in patients with schizophrenia. Schizophr Res 1999; 36: 272.
Conley R, Gale E, Hirsch K. Olanzapine response in therapy-refractory schizophrenia with substance abuse (SA) [abstract]. Schizophr Res 1997; 24: 190.
Weiden PJ. Quetiapine ('seroquel'): a new 'atypical' antipsychotic. J Prac Psychiatry and Behav Health 1997; 3(6): 368-374.
Responsible Party: Alan Green, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00156715     History of Changes
Other Study ID Numbers: 16563
IRUSQUET0063 ( Other Grant/Funding Number: AstraZeneca )
First Submitted: September 6, 2005
First Posted: September 12, 2005
Results First Submitted: November 19, 2010
Results First Posted: December 21, 2010
Last Update Posted: March 14, 2018