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An Investigation of Sleep Architecture in Ziprasidone-Treated Bipolar Depression

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: NCT00835107
Recruitment Status : Completed
First Posted : February 3, 2009
Last Update Posted : December 16, 2015
Providence Health & Services
MDS Pharma Services
Information provided by (Responsible Party):
Dr. Roumen Milev, Queen's University

Brief Summary:
This study uses polysomnographs(PSG) to investigate sleep patterns in patients with bipolar depression. This is a double-blind, placebo-controlled, study of ziprasidone that is added to patients current medications. The objective is to relate changes in slow wave and rapid eye movement sleep to changes in mood and overall illness severity. Participants will be randomly assigned to add either placebo or ziprasidone to their current treatment regimen. Participants make 3 to 4 study visits, over a 1 month period, at which they will be asked about their history, mood and sleep quality. Participants will also have three in-home overnight polysomnographs.

Condition or disease Intervention/treatment Phase
Depression, Bipolar Drug: ziprasidone hydrochloride Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Investigation of Sleep Architecture in Ziprasidone-Treated Bipolar Depression
Study Start Date : February 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ziprasidone Drug: ziprasidone hydrochloride
oral capsules, from 40-80 mg BID, for one month with the option to continue the medication after the study has been completed
Other Name: Zeldox

Placebo Comparator: Sugar pill Drug: placebo
placebo comparator, oral capsules, BID, for one month

Primary Outcome Measures :
  1. To assess the objective (polysomnographic) changes in sleep quality before and after introduction of Ziprasidone in treatment of patients with bipolar depression. [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. To assess the subjective changes in sleep quality parameters before and at different stages after introduction of ziprasidone in treatment, longitudinally, and to correlate these changes with measures of illness severity. [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A diagnosis of Bipolar Disorder Type 1,2 or NOS by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV).
  • Current depressive episode with a HAMD-17 of >16.
  • Males or Females over age 18yrs.
  • Inpatients or outpatients.
  • 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.
  • Provision of written informed consent.

Exclusion Criteria:

  • Current Manic, Hypomanic or Mixed episode, with YMRS > 12.
  • Current or past diagnosis of Schizophrenia and Dementia.
  • Pregnant women, or women in childbearing age, not willing to use appropriate contraception or women currently nursing.
  • Patient on any other 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 Ziprasidone, as judged by the investigator.
  • Benzodiazepines and all other sleep-aids must be discontinued prior to participation in the study if they have not been at a stable dosage for the 4 weeks previous to entry into the study.
  • No change to the current medication regime (excluding discontinuation of sleep aids and antipsychotic medications) is allowed 4 weeks prior to the first PSG reading.
  • Administration of a depot antipsychotic injection within two dosing interval (for the depot) before randomization.
  • Substance or alcohol dependence at enrolment or in the last three months (except for caffeine or nicotine dependence), as defined by DSM-IV criteria.
  • Serious, unstable or inadequately treated medical illness as judged by the investigator.
  • History of epilepsy or uncontrolled seizures.
  • Involvement in the planning and conduct of the study.
  • Previous enrolment in the present study.
  • Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements.
  • Patients with serum potassium, magnesium and/or calcium levels outside the normal range at baseline.
  • Patients with marked liver function abnormalities at baseline, demonstrated by laboratory values, by judgment of the investigator.
  • Known serological evidence of HIV, or acute or chronic hepatitis; donation of blood or blood products for transfusion prior to initiation of the treatment with study drug, during the study and for 30 days after the study has ended.
  • Known history of QT prolongation (including congenital long QT syndrome).
  • Recent acute myocardial infarction or uncompensated heart failure.
  • Currently taking other drugs that are known to prolong the QT interval.

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): NCT00835107

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Canada, Ontario
Providence Care Mental Health Services
Kingston, Ontario, Canada, K7L 4X3
Sponsors and Collaborators
Queen's University
Providence Health & Services
MDS Pharma Services
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Principal Investigator: Roumen Milev, MD Queen's University
Principal Investigator: Anusha Baskaran, BScH Queen's University

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Responsible Party: Dr. Roumen Milev, MD, PhD, FRCPsych, FRCPC, Queen's University Identifier: NCT00835107     History of Changes
Other Study ID Numbers: PSIY-287-08
First Posted: February 3, 2009    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015
Keywords provided by Dr. Roumen Milev, Queen's University:
Bipolar Depression
Slow Wave Sleep
Additional relevant MeSH terms:
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Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents