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Sponsors and Collaborators: |
Queen's University AstraZeneca |
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Information provided by: | Queen's University |
ClinicalTrials.gov Identifier: | NCT00616889 |
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.
Condition | Intervention | Phase |
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Bipolar Disorder |
Drug: Seroquel |
Phase I |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Effects of Seroquel on Sleep Architecture in Patients With Bipolar Depression or Major Depressive Disorder - An Open Label Study |
Enrollment: | 15 |
Study Start Date: | May 2006 |
Study Completion Date: | January 2009 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Seroquel added to medication regime and sleep quality measured
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Drug: Seroquel
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.
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Primary Objective:
To assess the objective (polysomnographic) change in sleep quality before and after introduction of Seroquel (Quetiapine) in treatment of patients with Bipolar Depression or Major Depressive Disorder.
Secondary Objectives:
To assess the objective (polysomnographic) and subjective changes in sleep quality parameters before and at different stages after introduction of Seroquel (Quetiapine) treatment, longitudinally, and to correlate these changes with measures of illness severity.
Study Design:
Prospective polysomnographic (PSG) study of patients before and after treatment with Seroquel (Quetiapine). PSG recordings will be done three (optional four) times during the study: before starting the Seroquel (Quetiapine) (baseline), at day 2 to 4 (early) and day 21 to 28 (longer term). (Optional fourth PSG can be done at day 42-56).
PSG will be completed at patients home with a portable PSG.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Adults with current Major Depressive Disorder or Bipolar Depression
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Queen's University at Kingston ( Dr. Roumen Milev ) |
Study ID Numbers: | PSIY-206-05, D1449C00011 |
Study First Received: | September 9, 2005 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00616889 History of Changes |
Health Authority: | Canada: Health Canada |
Depression Tranquilizing Agents Bipolar Disorder Psychotropic Drugs Central Nervous System Depressants Depressive Disorder, Major Depressive Disorder |
Antipsychotic Agents Behavioral Symptoms Affective Disorders, Psychotic Quetiapine Mental Disorders Mood Disorders Psychotic Disorders |
Depression Disease Tranquilizing Agents Bipolar Disorder Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Depressive Disorder, Major Depressive Disorder Antipsychotic Agents |
Pharmacologic Actions Behavioral Symptoms Affective Disorders, Psychotic Quetiapine Pathologic Processes Mental Disorders Therapeutic Uses Mood Disorders Central Nervous System Agents |