An Investigation of Sleep Architecture in Ziprasidone-Treated Bipolar Depression

Depression, Bipolar Clinical Trial

Official title:

An Investigation of Sleep Architecture in Ziprasidone-Treated Bipolar Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00835107
• Other study ID #: PSIY-287-08
• Secondary ID: GA128250
• Status: Completed
• Phase: Phase 4
• First received: February 2, 2009
• Last updated: December 14, 2015
• Start date: February 2009
• Est. completion date: June 2011

Study information

• Verified date: December 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depression, Bipolar
• Depressive Disorder

Intervention

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
• placebo
placebo comparator, oral capsules, BID, for one month

Locations

Country	Name	City	State
Canada	Providence Care Mental Health Services	Kingston	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Queen's University	MDS Pharma Services, Pfizer, Providence Health & Services

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Cohrs S, Meier A, Neumann AC, Jordan W, Rüther 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. — View Citation

Sharpley AL, Cowen PJ. Effect of pharmacologic treatments on the sleep of depressed patients. Biol Psychiatry. 1995 Jan 15;37(2):85-98. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the objective (polysomnographic) changes in sleep quality before and after introduction of Ziprasidone in treatment of patients with bipolar depression.		1 month	No
Secondary	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	No