An Investigation of Sleep Architecture in Ziprasidone-Treated Bipolar Depression

NCT00835107 | Completed Phase 4

• 2 other identifiers: PSIY-287-08GA128250
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Bipolar

Keywords

Bipolar Depression; Sleep; Polysomnograph; Slow Wave Sleep; Ziprasidone; Antipsychotic; Placebo

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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.

  1 month

Study Arms (2)

Ziprasidone

EXPERIMENTAL

Drug: ziprasidone hydrochloride

Sugar pill

PLACEBO COMPARATOR

Drug: placebo

Interventions

ziprasidone hydrochloride DRUG

oral capsules, from 40-80 mg BID, for one month with the option to continue the medication after the study has been completed

Also known as: Zeldox

Ziprasidone

placebo DRUG

placebo comparator, oral capsules, BID, for one month

Sugar pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University: lead
• Providence Health & Services: collaborator
• Pfizer: collaborator
• MDS Pharma Services: collaborator

Study Sites (1)

Providence Care Mental Health Services

Kingston, Ontario, K7L 4X3, Canada

Location

Related Publications (2)

• 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.

  PMID: 16086613 BACKGROUND

• 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.

  PMID: 7718684 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Roumen Milev, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

• Anusha Baskaran, BScH

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FRCPsych, FRCPC

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 3, 2009
• Study Start: February 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

CA (1)