Tranylcypromine Treatment of Bipolar Depression
Information source: New York State Psychiatric Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder I or II
Intervention: Tranylcypromine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: New York State Psychiatric Institute Overall contact:
Vito Agosti, M.S.W., Phone: 212-543-5605, Email: agostiv@nyspi.columbia.edu
Summary
This study seeks to investigate whether tranylcypromine (Parnate®) might be an effective
treatment of bipolar depression. New treatments are needed, as there is little evidence that
standard antidepressants are effective in treating this condition, and the two antipsychotic
medications that have indications for bipolar depression can cause substantial side effects.
This study will focus specifically on currently depressed outpatients having a bipolar
history for whom at least one standard antidepressant medication was ineffective. Patients
will be treated openly with tranylcypromine for 8-10 months, depending on treatment
response.
Clinical Details
Official title: Tranylcypromine Treatment of Bipolar Depression
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Hamilton Rating Scale for Depression (HAMD)
Secondary outcome: Quick Inventory of Depressive Illness (QIDS)Symptom Check List - 90 items (SCL-90) Patient Global Impression Scale (PGI) Modified Clinical Monitoring Form (M-CMF) Social Adjustment Scale (SAS)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Vito Agosti, M.S.W., Phone: 212-543-5605, Email: agostiv@nyspi.columbia.edu
New York State Psychiatric Institute, New York, New York 10032, United States; Recruiting
Vito Agosti, M.S.W., Phone: 212-543-5605, Email: agostiv@nyspi.columbia.edu
Jonathan W Stewart, M.D., Principal Investigator
David J Hellerstein, M.D., Sub-Investigator
Deborah A Deliyannides, M.D., Sub-Investigator
Patrick J McGrath, M.D., Sub-Investigator
Robin Bell, M.D., Sub-Investigator
Additional Information
Depression Evaluation Service
Starting date: May 2011
Last updated: December 14, 2011
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