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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00616889
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : December 16, 2015
Information provided by (Responsible Party):
Dr. Roumen Milev, Queen's University

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.

Condition or disease Intervention/treatment
Bipolar Disorder Drug: Seroquel

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Seroquel on Sleep Architecture in Patients With Bipolar Depression or Major Depressive Disorder - An Open Label Study
Study Start Date : May 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Group/Cohort Intervention/treatment
Seroquel added to medication regime and sleep quality measured
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.
Other Name: Quetiapine

Primary Outcome Measures :
  1. Sleep quality as measured by overnight PSG. [ Time Frame: baseline, day 2 to 4 (early) and day 21 to 28 (longer term). Optional reading at day 42-56 ]

Information from the National Library of Medicine

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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
Sampling Method:   Non-Probability Sample
Study Population
Adults with current Major Depressive Disorder or Bipolar Depression

Inclusion Criteria:

  1. Provision of written informed consent;
  2. 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
  3. Males or Females aged 18 years or more;
  4. 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;
  5. Able to understand and comply with the requirements of the study;
  6. Current depressive episode with a HAM-D17 score of 15 or more.

Exclusion Criteria:

  1. Current Manic, Hypomanic or Mixed episode, with YMRS 12 or more;
  2. Current or past diagnosis of Schizophrenia;
  3. Pregnant women, or women in childbearing age, not willing to use appropriate contraception or women currently nursing;
  4. Patient on antipsychotic medication;
  5. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others;
  6. Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator;
  7. 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;
  8. 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;
  9. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization;
  10. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria;
  11. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen dependence by DSM-IV criteria within 4 weeks prior to enrolment;
  12. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment;
  13. Unstable or inadequately treated medical illness (e.g., diabetes, angina pectoris, hypertension) as judged by the investigator;
  14. Involvement in the planning and conduct of the study;
  15. Previous enrolment in the present study;
  16. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements;
  17. If participant's liver function testing is rated 2 in the upper limits of normal.
  18. Diagnosis of Dementia
  19. Regular use of benzodiazepines unless at a stable dose for at least 12 weeks.

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 identifier (NCT number): NCT00616889

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Canada, Ontario
Pccc, Mhs
Kingston, Ontario, Canada, K7L 4X3
Sponsors and Collaborators
Queen's University
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Principal Investigator: Roumen V Milev, MD Queen's University

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Responsible Party: Dr. Roumen Milev, Principal Investigator, Queen's University Identifier: NCT00616889    
Other Study ID Numbers: PSIY-206-05
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs