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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01430455 |
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Date of registration:
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06/09/2011 |
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Primary sponsor: |
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Public title:
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Tranylcypromine Treatment of Bipolar Depression
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Scientific title:
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Tranylcypromine Treatment of Bipolar Depression |
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Date of first enrolment:
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May 2011 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01430455 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Vito Agosti, M.S.W. |
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Address:
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Telephone:
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212-543-5605 |
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Email:
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agostiv@nyspi.columbia.edu |
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Affiliation:
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Name:
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Vito Agosti, M.S.W. |
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Address:
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Telephone:
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212-543-5605 |
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Email:
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agostiv@nyspi.columbia.edu |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. History of Bipolar I, II
2. Currently depressed (major depressive episode or depression NOS)
3. Physically healthy or physically stable (i.e.,No changes in medical interventions in
past three months or likely for the next three months)
4. On stable and effective mood stabilizer or hypomania deemed sufficiently mild to not
require a mood stabilizer.
5. Prior adequate trial on at least one antidepressant.
6. Able to follow a tyramine-free diet
7. Must speak English
Exclusion Criteria:
1. Current psychosis
2. past psychosis not occurring during an episode of mania or depression
3. prior nonremission to tranylcypromine 60 mg/d (or greater)
4. currently taking effective medication precluded while taking a MAOI (e.g., a
psychostimulant or a serotonin re-uptake inhibitor)
5. current (last six months) drug or alcohol abuse or dependence
6. significant suicide risk
7. significant cardiovascular risk
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bipolar Disorder I or II
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Intervention(s)
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Drug: Tranylcypromine
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Primary Outcome(s)
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Hamilton Rating Scale for Depression (HAMD)
[Time Frame: Weekly or bi-weekly for 16 week study duration]
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Secondary Outcome(s)
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Modified Clinical Monitoring Form (M-CMF)
[Time Frame: Weekly or bi-weekly throughout the 16 week study]
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Patient Global Impression Scale (PGI)
[Time Frame: Weekly or bi-weekly throughout the 16 week study]
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Quick Inventory of Depressive Illness (QIDS)
[Time Frame: Weekly or bi-weekly for entire 16 week study duration]
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Social Adjustment Scale (SAS)
[Time Frame: Administered four times throughout the 16 week study]
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Symptom Check List - 90 items (SCL-90)
[Time Frame: Administered four times throughout 16 week study]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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