Quetiapine in Co-Morbid Depressive and Anxiety Disorders

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arun Ravindran, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT00688818
First received: May 30, 2008
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

This multi-centred study will be conducted at three centres. The design will be a randomized, placebo-controlled, parallel-group one. This investigation will evaluate the efficacy of add-on Quetiapine XR (extended release) treatment for patients who meet diagnostic criteria for depressive disorders and one or more comorbid anxiety disorder.


Condition Intervention
Major Depressive Disorder
Dysthymic Disorder
Anxiety Disorders
Generalized Anxiety Disorder
Social Anxiety Disorder
Panic Disorder
Post-traumatic Stress Disorder
Drug: Quetiapine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Placebo-Controlled Effectiveness Study of Quetiapine XR in Co-Morbid Depressive and Anxiety Disorders

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hamilton Anxiety Scale [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
  • Quality of Life Enjoyment and Satisfaction Scale [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
  • Penn State Worry Questionnaire [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
  • Panic Disorder Severity Scale [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
  • Leibowitz Social Anxiety Scale [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
  • Post-traumatic Diagnostic Scale [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression Scale [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: June 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quetiapine and existing psychotropics Drug: Quetiapine
Patients will be initiated on 50 mg of Quetiapine XR and will be titrated to a maximum dose of 300 mg based on response and tolerability. Dosing will be flexible up to Week 8, and then will remain fixed for until the end of the 12 week period.
Other Name: Seroquel
Placebo Comparator: Placebo and existing psychotropics Drug: Placebo
Patients will be initiated on 50 mg of Placebo and will be titrated to a maximum dose of 300 mg based on response and tolerability. Dosing will be flexible up to Week 8, and then will remain fixed for until the end of the 12 week period.

Detailed Description:

The primary objective is to examine the beneficial effect of quetiapine augmentation of first-line antidepressants in refractory depression with co-morbid anxiety, compared to placebo. It is hypothesized that significant improvement on depression and anxiety symptoms will be seen as evidenced by reduction in Hamilton Depression Rating Scale (HAMD-17) and Hamilton Anxiety Scale (HAMA) scores after the 12 week treatment period for those who received Quetiapine XR augmentation compared to those who received placebo.2.2

Secondary objectives: 1) To establish the tolerability and safety of Quetiapine XR versus Placebo in patients with co-morbid depressive and anxiety disorders;2) To assess and compare the efficacy of Quetiapine XR versus Placebo improving quality of life in patients with co-morbid depressive and anxiety disorders.; 3) To assess and compare the efficacy of Quetiapine XR versus Placebo on clinical measures symptoms associated to co-morbid depressive and anxiety disorders.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of written informed consent
  • Male and female patients must be of 18 to 65 years of age.
  • Women of childbearing potential must have a negative pregnancy test and must, in the investigator's opinion, practice a clinically accepted, reliable method of contraception during this study.
  • A diagnosis of Major Depressive Disorder or Dysthymic Disorder as defined by DSM-IV criteria and failed to respond to at least one first line treatment. The patient must be receiving antidepressant treatment (SSRIs, SNRIs or mirtazapine).
  • A co-morbid diagnosis of one or more of the following: Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, and Post Traumatic Stress Disorder, and Obsessive-Compulsive Disorder, as defined by DSM-IV criteria
  • A minimum score of ≥17 at Baseline on the 17-item HAM-D.
  • Able to understand and comply with the requirements of the study

Exclusion Criteria:

  • The presence or history of Psychotic Disorders, Bipolar Disorders, Mood Disorders with Psychotic Features
  • Patients who, in the investigator's judgment, would require treatment with additional psychotherapeutic drugs, electroconvulsive therapy (ECT), or intensive psychotherapy during the course of the study.
  • ECT within the preceding 6 months of screening before inclusion.
  • Regular, formal psychotherapy (excluding supportive therapy) started within the last 3 months before inclusion.
  • Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
  • Known intolerance or lack of response to quetiapine fumarate.
  • Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment
  • Use of any of the following significant cytochrome P450 inducers in the 14 days preceding enrolment
  • Patients who are currently receiving: monoamine oxidase inhibitors, tricyclic antidepressants, oral neuroleptics, or type 1C anti-arrhythmics within two weeks of screening; herbal psychoactive treatments (St. John's Wort, Kava Kava, Gingko Biloba) within two weeks of screening.
  • Patients taking SSRIs or SNRIs for less than two weeks or at a less than therapeutic dose prior to enrolment.
  • Patients who require concurrent psychotropic medication other than allowed medication specified in protocol.
  • Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation.
  • Patients who have met DSM-IV criteria for abuse of or dependence on any drug, including alcohol within 3 months prior to screening.
  • Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
  • Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
  • Patients with clinically significant abnormalities in hematology, clinical chemistry, urinalysis or ECG at the screening visit.
  • Involvement in the planning and conduct of the study
  • Previous enrolment or randomisation of treatment in the present study.
  • Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
  • A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:a)Unstable DM (HbA1c) >8.5%, b) hospital admission for DM or DM related illness in past 12 weeks, c)not under physician care for DM, d) physician responsible for patient's DM care has not approved patient's participation in the study,or indicated DM is controlled e)change in dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation. For thiazolidinediones (glitazones) this period will not be less than 8 weeks, g)taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks (Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study)
  • An absolute neutrophil count (ANC) of <= 1.5 x 10^9 per
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688818

Locations
Canada, Ontario
Chatham-Kent Health Alliance
Chatham, Ontario, Canada, N7L1B7
Centre for Neuropsychiatric Study
Markham, Ontario, Canada, L6B 1A1
Credit Valley Medical Arts Centre
Mississauga, Ontario, Canada, L5M 4N4
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
Principal Investigator: Arun Ravindran, MD, PhD Centre for Addiction and Mental Health
  More Information

Additional Information:
No publications provided

Responsible Party: Arun Ravindran, Principal Investigator, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00688818     History of Changes
Other Study ID Numbers: 183/2007
Study First Received: May 30, 2008
Last Updated: August 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:
Co-morbid depressive and anxiety disorders
Quetiapine
Randomized
Placebo-controlled
Double-blind
Major depressive disorder
Dysthymic disorder
Anxiety disorders
Generalized anxiety disorder
Social anxiety disorder
Panic disorder
Post-traumatic stress disorder

Additional relevant MeSH terms:
Anxiety Disorders
Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Panic Disorder
Phobic Disorders
Dysthymic Disorder
Mental Disorders
Mood Disorders
Behavioral Symptoms
Pathologic Processes
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 30, 2014