NCT00835107

An Investigation of Sleep Architecture in Ziprasidone-Treated Bipolar Depression

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Queen's University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2009-02-03
• Last updated: 2015-12-16

Locations

1 site across 1 country: Canada