Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT00237666
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00237666
Study Brief:
Protocol Section:
NCT00237666