Bipolar Disorder I or IIPhase 4NCT01430455

Tranylcypromine Treatment of Bipolar Depression

A Phase 4 study testing Tranylcypromine in people with Bipolar Disorder I or II, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Bipolar Disorder I or II
What is being tested?: Tranylcypromine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: Nov 2011to Sep 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

History of Bipolar I, II
Currently depressed (major depressive episode or depression NOS)
Physically healthy or physically stable (i.e.,No changes in medical interventions in past three months or likely for the next three months)
On stable and effective mood stabilizer or hypomania deemed sufficiently mild to not require a mood stabilizer.
Prior adequate trial on at least one antidepressant.
Able to follow a tyramine-free diet
Must speak English

Who cannot join

Current psychosis
past psychosis not occurring during an episode of mania or depression
prior nonremission to tranylcypromine 60 mg/d (or greater)
currently taking effective medication precluded while taking a Monoamine Oxidase Inhibitor (e.g., a psychostimulant or a serotonin re-uptake inhibitor)
current (last six months) drug or alcohol abuse or dependence
significant suicide risk
significant cardiovascular risk

Trial locations and contacts

1 site in 1 country.

United States1 site

New York State Psychiatric Institute
New York, New York, 10032

Other trials in United States

About this study

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.

Conditions: Bipolar Disorder I or II
Being tested: Tranylcypromine
Keywords: Major Depressive Episode, Depression NOS, Bipolar Disorder, Bipolar Disorder I, Bipolar Disorder II, Bipolar Depression, Major Depression
Medical subject headings: Depression, Bipolar Disorder, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TranylcypromineDrug
Also called Parnate®
Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study

Study groups in NCT01430455
Study group	Role	What they receive
Tranylcypromine	Experimental	Active, open-label tranylcypromine treatment Receives: Drug: Tranylcypromine

What is being measured

The primary outcome is the main question the study is designed to answer.

29 Item Hamilton Rating Scale for Depression (HamD29)
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.
Measured: Hamilton 29 score at baseline (start date of medication) and week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Sep 2014

First posted8 Sep 2011 (estimated)
Study startNov 2011
Primary completionFeb 2014
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bipolar Disorder I or IIStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01430455
Sponsor's protocol ID: 6333
Status last verified: Feb 2018
First submitted: 6 Sep 2011
Last updated: 15 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
Active, not recruitingPhase 3
An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
Bipolar Depression, Bipolar I Disorder
Active, not recruitingPhase 3
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Bipolar Disorder, Bipolar Depression
RecruitingPhase 2
ALTO-100 in Bipolar Disorder With Depression (BD-D)
Bipolar Disorder I or II With a Major Depressive Episode
Active, not recruitingPhase 2
Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder
Bipolar I or II Disorder

All Bipolar Disorder I or II trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tranylcypromine Treatment of Bipolar Depression
ClinicalTrials.gov ID: NCT01430455
Acronym / sponsor ID: 6333
Conditions: Bipolar Disorder I or II
Keywords: Major Depressive Episode, Depression NOS, Bipolar Disorder, Bipolar Disorder I, Bipolar Disorder II, Bipolar Depression, Major Depression
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: New York State Psychiatric InstituteUniversity, hospital or other
Study start: Nov 2011 (actual)
Primary completion: Feb 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 8 Sep 2011 (estimated)
Results: Posted 15 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tranylcypromine	Experimental	Drug: TranylcypromineActive, open-label tranylcypromine treatment

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

History of Bipolar I, II
Currently depressed (major depressive episode or depression NOS)
Physically healthy or physically stable (i.e.,No changes in medical interventions in past three months or likely for the next three months)
On stable and effective mood stabilizer or hypomania deemed sufficiently mild to not require a mood stabilizer.
Prior adequate trial on at least one antidepressant.

Key exclusion criteria (7 listed)

Current psychosis
past psychosis not occurring during an episode of mania or depression
prior nonremission to tranylcypromine 60 mg/d (or greater)
currently taking effective medication precluded while taking a Monoamine Oxidase Inhibitor (e.g., a psychostimulant or a serotonin re-uptake inhibitor)
current (last six months) drug or alcohol abuse or dependence

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TranylcypromineAlso: Parnate®Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study	Drug	Tranylcypromine

Primary outcome

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.

Results and safety

Results posted to the registry on 15 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tranylcypromine	7	5

Primary outcome: 29 Item Hamilton Rating Scale for Depression (HamD29)

Time frame: Hamilton 29 score at baseline (start date of medication) and week 16. Mean (Standard Error). Unit: Hamilton Depression score

Measure	Tranylcypromine n = 7
Baseline Score	27.0 (1.4)
Week 16 Score	5.8 (2.1)

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

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tranylcypromine	0 of 7 (0%)	6 of 7 (85.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Depression Evaluation ServiceLink provided by the sponsor.

Related trials for Bipolar Disorder I or II

RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
Active, not recruitingPhase 3
An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
Bipolar Depression, Bipolar I Disorder
Active, not recruitingPhase 3
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Bipolar Disorder, Bipolar Depression
RecruitingPhase 2
ALTO-100 in Bipolar Disorder With Depression (BD-D)
Bipolar Disorder I or II With a Major Depressive Episode
Active, not recruitingPhase 2
Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder
Bipolar I or II Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tranylcypromine in people with Bipolar Disorder I or II, run by New York State Psychiatric Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

29 Item Hamilton Rating Scale for Depression (HamD29) (time frame: Hamilton 29 score at baseline (start date of medication) and week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01430455.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.