Tranylcypromine Treatment of Bipolar Depression

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01430455
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arm: 1
• Actual Duration (Months): 34
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Tranylcypromine Treatment of Bipolar Depression
• Actual Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

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 Names: Parnate®

Outcome Measures

Primary Outcome Measures

1. 29 Item Hamilton Rating Scale for Depression (HamD29) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Depression Evaluation Service

Publications

None provided.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT01430455
• Other Study ID Numbers: 6333
• First Posted: Sep 8, 2011
• Last Update Posted: Mar 15, 2018
• Last Verified: Feb 1, 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; Tranylcypromine

Study Results

Participant Flow

Arm/Group Title	Tranylcypromine
Arm/Group Description	Active, open-label tranylcypromine treatment Tranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study
Period Title: Overall Study
STARTED	7
COMPLETED	5
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Tranylcypromine
Arm/Group Description	Active, open-label tranylcypromine treatment Tranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study
Overall Participants	7
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	7 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41 (15)
Sex: Female, Male (Count of Participants)
Female	6 85.7%
Male	1 14.3%
Region of Enrollment (Count of Participants)
United States	7 100%

Outcome Measures

1. Primary Outcome

Title	29 Item Hamilton Rating Scale for Depression (HamD29)
Description	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.
Time Frame	Hamilton 29 score at baseline (start date of medication) and week 16

Outcome Measure Data

Analysis Population Description

2 patients who did not make it to week 16 (one dropped out at week 3 and one dropped out at week 9)

Arm/Group Title	Tranylcypromine
Arm/Group Description	Active, open-label tranylcypromine treatment Tranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study
Measure Participants	7
Baseline Score	27.0 (1.4)
Week 16 Score	5.8 (2.1)

Adverse Events

Arm/Group Title	Tranylcypromine
Arm/Group Description	Active, open-label tranylcypromine treatment Tranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study
All Cause Mortality
	Tranylcypromine
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Tranylcypromine
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Other (Not Including Serious) Adverse Events
	Tranylcypromine
	Affected / at Risk (%)	# Events
Total	6/7 (85.7%)
Eye disorders
Light Sensitivity	1/7 (14.3%)	1
Gastrointestinal disorders
constipation	1/7 (14.3%)	1
General disorders
water retention	1/7 (14.3%)	2
Mild ataxia	2/7 (28.6%)	3
Dry Mouth	1/7 (14.3%)	1
Metabolism and nutrition disorders
Weight gain	1/7 (14.3%)	1
increased appetite	1/7 (14.3%)	1
Musculoskeletal and connective tissue disorders
Knee pain	1/7 (14.3%)	1
muscle tension	1/7 (14.3%)	1
Leg cramps	1/7 (14.3%)	1
Nervous system disorders
insomnia	1/7 (14.3%)	1
Syncope	1/7 (14.3%)	1
Vascular disorders
Lightheadedness	2/7 (28.6%)	2
postural hypotension	1/7 (14.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.