An Investigation of Sleep Architecture in Ziprasidone-Treated Bipolar Depression

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.

Study Overview

• Status: Completed
• Conditions: Depression, Bipolar
• Intervention / Treatment: Drug: ziprasidone hydrochloride; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 4X3
      • Providence Care Mental Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Sugar pill	Drug: placebo; placebo comparator, oral capsules, BID, for one month
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 Names: Zeldox

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	1 month

Collaborators and Investigators

• Sponsor: Queen's University
• Collaborators: Pfizer; Providence Health & Services; MDS Pharma Services
• Investigators: Principal Investigator: Anusha Baskaran, BScH, Queen's University

Publications and helpful links

General Publications

• Cohrs S, Meier A, Neumann AC, Jordan W, Ruther E, Rodenbeck A. Improved sleep continuity and increased slow wave sleep and REM latency during ziprasidone treatment: a randomized, controlled, crossover trial of 12 healthy male subjects. J Clin Psychiatry. 2005 Aug;66(8):989-96. doi: 10.4088/jcp.v66n0805.
• Sharpley AL, Cowen PJ. Effect of pharmacologic treatments on the sleep of depressed patients. Biol Psychiatry. 1995 Jan 15;37(2):85-98. doi: 10.1016/0006-3223(94)00135-P.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: February 2, 2009
• First Submitted That Met QC Criteria: February 2, 2009
• First Posted (ESTIMATE): February 3, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Sleep; Bipolar Depression; Placebo; Antipsychotic; Polysomnograph; Ziprasidone; Slow Wave Sleep
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Depression; Depressive Disorder; Bipolar Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Ziprasidone
• Other Study ID Numbers: PSIY-287-08; GA128250