Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression

Completed · Phase 4

Conditions studied: Bipolar II Disorder, Major Depressive Episode

In brief

The purpose of this study is to evaluate the antidepressant effectiveness of Geodon for the treatment of patients diagnosed with Bipolar II disorder who are currently experiencing a major depressive episode.

Key facts

Study ID

NCT00237666

Run by

The Medical Research Network

People needed

30

Starts

2005-02-01

Expected to finish

2008-02-01

Last updated by the study team

2013-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• patients will meet DSM-IV criteria for Bipolar II Disorder, with at least one hypomanic episode as documented in the medical history or provided by an informant, or have evidence of a clear diagnosis of hypomania
• patients will currently be experiencing a major depressive episode of 2 or more weeks, but less than 12 months duration
• minimum score of 18 on the 17-item HAM-D at screen and baseline

You may not qualify if…

• patients will not meet criteria for Bipolar I or Schizoaffective Disorder or Schizophrenia
• patients may have co-morbid anxiety or other Axis I disorders as long as depression dominates the clinical picture
• Suicidal ideation or history that makes participation in a clinical trial unduly risky
• unstable medical conditions or any abnormality in thyroid function
• patients with a QTc of 450msec or greater on the initial ECG
• patients requiring concomitant psychotropic drugs will not be eligible, although patients on such drugs who can undergo washout will be eligible. such patients must have discontinued psychoactive drugs at least 2 weeks before beginning study, with 4 weeks for fluoxetine and depot neuroleptics
• the use of Zolpidem 5-10 mg as needed will be permitted for patients suffering from insomnia, but cannot be taken the night before a scheduled assessment
• patients with dementia or substance abuse in the last 6 months
• pregnant or lactating women will be excluded, as will those not using adequate forms of contraception

Where it is running

• Medical Research Network, L.L.C. — New York, New York, United States
• The Mech Center — Plano, Texas, United States

Full record on ClinicalTrials.gov

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