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Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat

NCT01971203 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2018-02-15

Study results available
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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.

Conditions

Interventions

DRUG

seroquel xr

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

BEHAVIORAL

CBT

16 weeks of treatment

Sponsors & Collaborators

Principal Investigators

  • Jack Hirschowitz, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01971203 on ClinicalTrials.gov