ClinicalTrials.gov
ClinicalTrials.gov Menu

Tranylcypromine Treatment of Bipolar Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01430455
Recruitment Status : Completed
First Posted : September 8, 2011
Results First Posted : March 15, 2018
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder I or II Drug: Tranylcypromine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tranylcypromine Treatment of Bipolar Depression
Actual Study Start Date : November 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tranylcypromine
Active, open-label tranylcypromine treatment
Drug: Tranylcypromine
Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study
Other Name: Parnate®




Primary Outcome Measures :
  1. 29 Item Hamilton Rating Scale for Depression (HamD29) [ Time Frame: Hamilton 29 score at baseline (start date of medication) and week 16 ]
    29 Item Hamilton Rating Scale for Depression (HamD29) is the 29 item version of the most common depression rating scale. The scores represented here are the average scores at baseline and after 16 weeks of open label treatment. The scale is rated from 0-89 with higher scores representing a more depressed state.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 Monoamine Oxidase Inhibitor (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430455


Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute

Additional Information:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01430455     History of Changes
Other Study ID Numbers: 6333
First Posted: September 8, 2011    Key Record Dates
Results First Posted: March 15, 2018
Last Update Posted: March 15, 2018
Last Verified: February 2018

Keywords provided by New York State Psychiatric Institute:
Major Depressive Episode
Depression NOS
Bipolar Disorder
Bipolar Disorder I
Bipolar Disorder II
Bipolar Depression
Major Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Tranylcypromine
Antidepressive Agents
Psychotropic Drugs
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs