Quetiapine in Co-Morbid Depressive and Anxiety Disorders

NCT00688818 | Completed DMC

• 1 other identifier: 183/2007
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Major Depressive Disorder; Dysthymic Disorder; Anxiety Disorders; Generalized Anxiety Disorder; Social Anxiety Disorder; Panic Disorder; Post-traumatic Stress Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HAMD-17)

  12 weeks

Secondary Outcomes (7)

• Hamilton Anxiety Scale

  Baseline, 6 weeks and 12 weeks

• Quality of Life Enjoyment and Satisfaction Scale

  Baseline, 6 weeks and 12 weeks

• Penn State Worry Questionnaire

  Baseline, 6 weeks and 12 weeks

• Panic Disorder Severity Scale

  Baseline, 6 weeks and 12 weeks

• Leibowitz Social Anxiety Scale

  Baseline, 6 weeks and 12 weeks

Study Arms (2)

Quetiapine and existing psychotropics

EXPERIMENTAL

Drug: Quetiapine

Placebo and existing psychotropics

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Quetiapine DRUG

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.

Also known as: Seroquel

Quetiapine and existing psychotropics

Placebo DRUG

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.

Placebo and existing psychotropics

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
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (4)

Chatham-Kent Health Alliance

Chatham, Ontario, N7L1B7, Canada

Location

Centre for Neuropsychiatric Study

Markham, Ontario, L6B 1A1, Canada

Location

Credit Valley Medical Arts Centre

Mississauga, Ontario, L5M 4N4, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Publications (1)

• Ravindran N, McKay M, Paric A, Johnson S, Chandrasena R, Abraham G, Ravindran AV. Randomized, Placebo-Controlled Effectiveness Study of Quetiapine XR in Comorbid Depressive and Anxiety Disorders. J Clin Psychiatry. 2022 Mar 21;83(3):21m14096. doi: 10.4088/JCP.21m14096.

  PMID: 35324094 DERIVED

Related Links

• Information about research at the Centre for Addiction and Mental Health

MeSH Terms

Conditions

Depressive Disorder, Major; Dysthymic Disorder; Anxiety Disorders; Generalized Anxiety Disorder; Phobia, Social; Panic Disorder; Stress Disorders, Post-Traumatic

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Phobic Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Arun Ravindran, MD, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2008
• First Posted: June 3, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 21, 2014

Record last verified: 2014-08

Locations

CA (4)