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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

Page last updated: August 23, 2015

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