Effect of Quetiapine on Sleep Architecture in Bipolar Depression and Major Depressive Disorder

NCT00616889 | Completed

• 2 other identifiers: PSIY-206-05D1449C00011
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical practice indicates that Quetiapine has sedating properties, and its sedative effects may play an important role in restoring quality of sleep in patients with various psychiatric conditions who frequently experience sleep disturbances as part of their illness. It is well known that depressive disorders are very frequently associated with significant sleep disturbance. Sleep disruption is a feature of Bipolar Disorder during both Depressed and Manic/Hypomanic episodes. Considering that Seroquel has good antidepressant properties (Calabrese, 2004), the investigators suggest that Seroquel's effect on sleep architecture contributes to its antidepressant properties.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Sleep quality as measured by overnight PSG.

  baseline, day 2 to 4 (early) and day 21 to 28 (longer term). Optional reading at day 42-56

Study Arms (1)

1

Seroquel added to medication regime and sleep quality measured

Drug: Seroquel

Interventions

Seroquel DRUG

The dosage is flexible from 50-600 mg based on the investigator's clinical judgement and patient tolerance. It may be raised or lowered at will.

Also known as: Quetiapine

1

Eligibility Criteria

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

Study Population

Adults with current Major Depressive Disorder or Bipolar Depression

You may qualify if:

• Provision of written informed consent;
• A diagnosis of Bipolar Disorder Type 1,2 or NOS by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV);OR Major Depressive Disorder
• Males or Females aged 18 years or more;
• Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment;
• Able to understand and comply with the requirements of the study;
• Current depressive episode with a HAM-D17 score of 15 or more.

You may not qualify if:

• Current Manic, Hypomanic or Mixed episode, with YMRS 12 or more;
• Current or past diagnosis of Schizophrenia;
• Pregnant women, or women in childbearing age, not willing to use appropriate contraception or women currently nursing;
• Patient on antipsychotic medication;
• 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, as judged by the investigator;
• Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment 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 enrolment 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 enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria;
• Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen dependence by DSM-IV criteria within 4 weeks prior to enrolment;
• 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 enrolment in the present study;

Sponsors & Collaborators

• Queen's University: lead
• AstraZeneca: collaborator

Study Sites (1)

Pccc, Mhs

Kingston, Ontario, K7L 4X3, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Roumen V Milev, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: February 15, 2008
• Study Start: May 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

CA (1)