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| ID | Type | Description | Link |
|---|---|---|---|
| GA128250 |
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| Name | Class |
|---|---|
| Providence Health & Services | OTHER |
| Pfizer | INDUSTRY |
| MDS Pharma Services | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ziprasidone | Experimental |
| |
| Sugar pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the objective (polysomnographic) changes in sleep quality before and after introduction of Ziprasidone in treatment of patients with bipolar depression. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roumen Milev, MD | Queen's University | Principal Investigator |
| Anusha Baskaran, BScH | Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Care Mental Health Services | Kingston | Ontario | K7L 4X3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16086613 | Background | 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. | |
| 7718684 | Background |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C092292 | ziprasidone |
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| placebo | Drug | placebo comparator, oral capsules, BID, for one month |
|
| 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. |