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

NCT01971203 | Completed Results

• 1 other identifier: GCO 09-0807
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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

Major Depressive Disorder; Generalized Anxiety Disorder

Keywords

seroquel XR; quetiapine XR; major depression; generalized anxiety disorder; CBT; co-morbid MDD

Outcome Measures

Primary Outcomes (1)

• MADRS

  Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-administered, with overall score ranges from 0 (normal) to 54 (severe depression). Score at 16 weeks as compared to baseline.

  baseline and 16 weeks

Secondary Outcomes (3)

• HAM-A

  baseline and 16 weeks

• Clinical Global Impression Scales for Severity and Improvement

  up to 16 weeks

• Changes in Sexual Functioning Questionnaire (CSFQ)

  baseline and week 16

Study Arms (2)

seroquel xr

EXPERIMENTAL

quetiapine target dosage will be 150 mg/day, beginning at 50 mg/day 16 weeks of treatment including CBT

Drug: seroquel xr

placebo plus CBT

PLACEBO COMPARATOR

treatment group receiving placebo pill plus CBT

Behavioral: CBT

Interventions

seroquel xr DRUG

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

Also known as: quetiapine XR

seroquel xr

CBT BEHAVIORAL

16 weeks of treatment

Also known as: cognitive behavioral therapy

placebo plus CBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent
• A diagnosis of both major depression (single episode or recurrent) and generalized anxiety disorder by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
• Females and/or males aged 18 to 65 years
• Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment
• Able to understand and comply with the requirements of the study

You may not qualify if:

• Pregnancy or lactation
• Any history of psychosis, bipolar disorder, schizophrenia, eating disorders or OCD
• Imminent risk of suicide or a danger to self or others
• Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
• Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
• Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
• Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization
• Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
• Substance abuse by DSM-IV criteria within 6 months prior to enrollment
• Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
• Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
• Involvement in the planning and conduct of the study
• Previous enrollment or randomization of treatment in the present study
• Participation in another drug trial within 4 weeks prior to enrollment into this study or longer in accordance with local requirements
• A patient with Diabetes Mellitus (DM)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• AstraZeneca: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Generalized Anxiety Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Anxiety Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

The limitations of this research are the small sample size and the high rate of subject drop-out between randomization and initiation of treatment.

Results Point of Contact

• Title: Cindy J. Aaronson, MSW, PhD
• Organization: Icahn School of Medicine at Mount Sinai

cindy.aaronson@mssm.edu

212-241-3169

Study Officials

• Jack Hirschowitz, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 29, 2013
• Study Start: September 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 15, 2018
• Results First Posted: February 15, 2018

Record last verified: 2018-01

Locations

US (1)