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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
14
oral capsules, from 40-80 mg BID, for one month with the option to continue the medication after the study has been completed
placebo comparator, oral capsules, BID, for one month
Providence Care Mental Health Services
Kingston, Ontario, Canada
To assess the objective (polysomnographic) changes in sleep quality before and after introduction of Ziprasidone in treatment of patients with bipolar depression.
Time frame: 1 month
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.
Time frame: 1 month
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