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An Investigation of Sleep Architecture in Ziprasidone-Treated Bipolar Depression

NCT00835107 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2015-12-16

No results posted yet for this study

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

Interventions

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

DRUG

placebo

placebo comparator, oral capsules, BID, for one month

Sponsors & Collaborators

  • Providence Health & Services

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • MDS Pharma Services

    collaborator INDUSTRY

  • Queen's University

    lead OTHER

Principal Investigators

  • Roumen Milev, MD · Queen's University

  • Anusha Baskaran, BScH · Queen's University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Canada

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00835107 on ClinicalTrials.gov