An Investigation of Sleep Architecture in Ziprasidone-Treated Bipolar Depression

This study has been completed.
Sponsor:
Collaborators:
Providence Health & Services
Pfizer
MDS Pharma Services
Information provided by (Responsible Party):
Anusha Baskaran, Queen's University
ClinicalTrials.gov Identifier:
NCT00835107
First received: February 2, 2009
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Depression, Bipolar
Drug: ziprasidone hydrochloride
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Investigation of Sleep Architecture in Ziprasidone-Treated Bipolar Depression

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: February 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835107

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

Publications:
Responsible Party: Anusha Baskaran, Co-Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT00835107     History of Changes
Other Study ID Numbers: PSIY-287-08, GA128250
Study First Received: February 2, 2009
Last Updated: November 21, 2011
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
Bipolar Depression
Sleep
Polysomnograph
Slow Wave Sleep
Ziprasidone
Antipsychotic
Placebo

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 26, 2014