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

Primary Purpose

Major Depressive Disorder, Generalized Anxiety Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

seroquel xr

CBT

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring seroquel XR, quetiapine XR, major depression, generalized anxiety disorder, CBT, co-morbid MDD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

seroquel xr

placebo plus CBT

Arm Description

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

treatment group receiving placebo pill plus CBT

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

HAM-A

Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item clinician-administered scale measuring symptoms with total scale from 0 (not present) to 56 (severe) to severe anxiety.

Clinical Global Impression Scales for Severity and Improvement

The Clinical Global Impression Scales for Severity and Improvement (CGI-I and CGI-S), both clinician rated, measures overall severity of symptoms and level of improvement on a seven-point scale from 0 (not applicable or not assessed) to 7, where 7 is the most severe. In order for a participant to be considered a treatment responder, he or she must receive a score of 1 (not ill or very much improved) or 2 (borderline mentally ill or much improved).

Changes in Sexual Functioning Questionnaire (CSFQ)

Changes in Sexual Functioning Questionnaire (CSFQ) at week 16 as compared to baseline. The CSFQ assesses interest, functioning, and satisfaction in sex on a six-point scale, where 1 is greater than normal and 6 is totally absent, with full range from 5 (greater than normal) to 30 (totally absent).

Full Information

NCT ID

NCT01971203

First Posted

October 23, 2013

Last Updated

January 18, 2018

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01971203

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This study will evaluate the efficacy of quetiapine extended-release as adjunctive therapy to cognitive behavioral therapy (CBT) compared to CBT plus placebo in the treatment of patients with comorbid major depression and generalized anxiety disorder. We will also evaluate the quality of life in patients with comorbid MDD/GAD, the response and remission rates by treatment group, changes in sleep quality, and tolerability of adjunctive quetiapine to CBT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder, Generalized Anxiety Disorder

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

seroquel xr

Arm Type

Experimental

Arm Description

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

Arm Title

placebo plus CBT

Arm Type

Placebo Comparator

Arm Description

treatment group receiving placebo pill plus CBT

Intervention Type

Drug

Intervention Name(s)

seroquel xr

Other Intervention Name(s)

quetiapine XR

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

CBT

Other Intervention Name(s)

cognitive behavioral therapy

Intervention Description

16 weeks of treatment

Primary Outcome Measure Information:

Title

MADRS

Description

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.

Time Frame

baseline and 16 weeks

Secondary Outcome Measure Information:

Title

HAM-A

Description

Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item clinician-administered scale measuring symptoms with total scale from 0 (not present) to 56 (severe) to severe anxiety.

Time Frame

baseline and 16 weeks

Title

Clinical Global Impression Scales for Severity and Improvement

Description

Time Frame

up to 16 weeks

Title

Changes in Sexual Functioning Questionnaire (CSFQ)

Description

Time Frame

baseline and week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jack Hirschowitz, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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