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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
QUET 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.

Participant Flow:   Overall Study
    QUET
STARTED   23 
COMPLETED   16 
NOT COMPLETED   7 



  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
QUET 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.

Baseline Measures
   QUET 
Overall Participants Analyzed 
[Units: Participants]
 23 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      23 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.8  (9.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  26.1% 
Male      17  73.9% 
Region of Enrollment 
[Units: Participants]
 
United States   23 


  Outcome Measures

1.  Primary:   Mean Number of Drinking Days Per Week   [ Time Frame: 12 Weeks ]

2.  Secondary:   Clinical Symptoms   [ Time Frame: 12 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
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.


  More Information

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
e-mail: chris.okeefe@hitchcock.org


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