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Trial record 36 of 450 for:    QUETIAPINE

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

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ClinicalTrials.gov Identifier: NCT01971203
Recruitment Status : Completed
First Posted : October 29, 2013
Results First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Jack Hirschowitz, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Generalized Anxiety Disorder Drug: seroquel xr Behavioral: CBT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: seroquel xr
quetiapine target dosage will be 150 mg/day, beginning at 50 mg/day 16 weeks of treatment including CBT
Drug: seroquel xr
Quetiapine target dosage will be 150 mg/day, beginning at 50 mg/day
Other Name: quetiapine XR

Placebo Comparator: placebo plus CBT
treatment group receiving placebo pill plus CBT
Behavioral: CBT
16 weeks of treatment
Other Name: cognitive behavioral therapy




Primary Outcome Measures :
  1. MADRS [ Time Frame: baseline and 16 weeks ]
    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 :
  1. HAM-A [ Time Frame: baseline and 16 weeks ]
    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.

  2. Clinical Global Impression Scales for Severity and Improvement [ Time Frame: up to 16 weeks ]
    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).

  3. Changes in Sexual Functioning Questionnaire (CSFQ) [ Time Frame: baseline and week 16 ]
    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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971203


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
AstraZeneca
Investigators
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Principal Investigator: Jack Hirschowitz, MD Icahn School of Medicine at Mount Sinai

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Responsible Party: Jack Hirschowitz, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01971203     History of Changes
Other Study ID Numbers: GCO 09-0807
First Posted: October 29, 2013    Key Record Dates
Results First Posted: February 15, 2018
Last Update Posted: February 15, 2018
Last Verified: January 2018
Keywords provided by Jack Hirschowitz, Icahn School of Medicine at Mount Sinai:
seroquel XR
quetiapine XR
major depression
generalized anxiety disorder
CBT
co-morbid MDD
Additional relevant MeSH terms:
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Quetiapine Fumarate
Disease
Anxiety Disorders
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mental Disorders
Mood Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs