CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 23 enrolled
Drug / intervention
Quetiapinedrug
Likely dose
Quetiapine 600 mg daily in divided dosesAI-extracted
Key inclusion· 7
  • Age 18 to 65 years
  • Diagnosis of schizophrenia or schizoaffective disorder
  • Meets SCID criteria for substance use disorder (alcohol or drug abuse/dependence)
  • Active substance use on at least 8 days in the 4 weeks prior to randomization
Key exclusion· 7
  • Current treatment with depot/decanoate antipsychotics, clozapine, or non-investigator-approved quetiapine doses
  • Pregnant, planning pregnancy, or unwilling to use acceptable birth control
  • Currently residing in a residential program for substance use disorder treatment
  • Baseline treatment with psychotropic medication intended to reduce substance use

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00156715
NCT00156715Phase 4Completed

Efficacy of Quetiapine in Treating Patients With Active Substance Use Disorder and Schizophrenia

Dartmouth-Hitchcock Medical Center·interventional·Posted Sep 12, 2005·Updated Mar 14, 2018

In Brief

A Phase 4 clinical trial evaluating Quetiapine for Schizophrenia and 4 related conditions. Completed, enrolled 23 participants across 4 sites.

Detailed Summary

The purpose of this study is to examine the efficacy of quetiapine (Seroquel) in reducing substance use in persons diagnosed with schizophrenia. The primary hypothesis is that quetiapine treatment will be associated with a decrease in substance use.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartMar 1, 2004
Primary CompletionSep 1, 2006
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 20.8 years ago

Interventions

Quetiapinedrug

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.