CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 62 enrolled
Drug / intervention
seroquel xr +1 moredrug
Likely dose
seroquel xr 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01971203
NCT01971203N/ACompleted

Double-blind, Randomized, Active Controlled Study of the Efficacy and Safety of Extended-release Quetiapine Fumarate (Seroquel XR) as Adjunctive Medication Therapy to Cognitive Behavioral Therapy in the Treat,Ent of Patients With Comorbid Major Depression and Generalized Anxiety Disorder

Icahn School of Medicine at Mount Sinai·interventional·Posted Oct 29, 2013·Updated Feb 15, 2018

In Brief

A clinical study evaluating seroquel xr and CBT for Major Depressive Disorder and Generalized Anxiety Disorder. Completed, enrolled 62 participants across 1 site.

Detailed Summary

The primary objective of the study is to determine whether quetiapine extended-release in combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo in treating depressive and anxiety symptoms in patients with both major depression and generalized anxiety disorder. Approximately 64 individuals (adults 18-65) will be randomly assigned to treatment group for 16 weeks. Weekly CBT sessions will be conducted lasting about 45 minutes and weekly visits with the study psychiatrist lasting about 20 minutes in which medication will be discussed. Both clinician administered and self-report measures will be used to compare groups before and after 16 weeks.

Study Details

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

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 29, 2013
Enrollment StartSep 1, 2009
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 12.7 years ago

Interventions

seroquel xrdrug

Quetiapine target dosage will be 150 mg/day, beginning at 50 mg/day

CBTbehavioral

16 weeks of treatment