NCT00535262

Brief Summary

This pilot study will evaluate the efficacy of the monoamine oxidase inhibitor (MAOI)EmSam, a selegiline transdermal system (STS), in bipolar depression.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

October 28, 2014

Completed
Last Updated

October 28, 2014

Status Verified

May 1, 2013

Enrollment Period

4.9 years

First QC Date

September 24, 2007

Results QC Date

October 1, 2014

Last Update Submit

October 24, 2014

Conditions

Bipolar Depression

Keywords

Bipolardepression

Outcome Measures

Primary Outcomes (1)

  • Reduction of Depression CGI Score (<= 2)

    HAM-D score. Young Mania Scale Life Chart Method Patient Global Impression Symptom Checklist - 90 Quality of Life Enjoyment and Satisfaction Questionnaire 0 participants analyzed due to early termination of study.

    8 weeks

Study Arms (1)

EmSam

EXPERIMENTAL

EmSam will be administered in open-label fashion for 8-weeks during phase I of the study during which symptoms of depression will be assessed weekly. Those whose depression responds after 8-weeks will be entered into an 8-month open-label continuation phase during which they will be maintained on EmSam and be assessed on a monthly basis.

Drug: EmSam

Interventions

EmSamDRUG

Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch

Also known as: Selegiline Transdermal
EmSam

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 - 65
  • DSM-IV Bipolar Disorder (I, II, NOS), Depressed Phase
  • DSM-IV Bipolar Disorder (I,II, NOS), Mixed state with adequate mood stabilization (ie, resolution of manic or hypomanic symptoms for 8 weeks with a minimum of 4 weeks on a stable dose of mood-stabilizing medication that will be continued through all phases of the study).
  • Prior failure of or inability to tolerate at least one other antidepressant treatment
  • Physically healthy
  • Agrees to participate in the study
  • HAM-D 24 \> 10

You may not qualify if:

  • Bipolar Disorder (I, II, NOS), Mixed State without adequate mood stabilization
  • Prior significant adverse reaction to EmSam
  • Unstable medical disorder
  • History of epilepsy (febrile seizure o.k.)
  • Current use of any medication that might interact with EnSam.
  • Use within 2 weeks of other antidepressant medication (6 weeks for fluoxetine)
  • Inability to adhere to a tyramine-free diet
  • Recent (past 6 months) suicide attempt
  • Serious suicidal ideation
  • Pregnant
  • Breast feeding
  • Fecund, sexually active females, without adequate contraception
  • Prior failure to respond to 2 or more adequate oral MAOI trials (2/3 PDR maximum dose, minimum 4 weeks)
  • Non-nicotine substance abuse/dependence within the past 6 months (1 year for amphetamines/cocaine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Links

MeSH Terms

Conditions

Bipolar DisorderDepression

Interventions

Selegiline

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic Chemicals

Limitations and Caveats

Early termination due to lack of financial support; only 3 participants were entered into the study; no data was analyzed.

Results Point of Contact

Title
Deborah A. Deliyannides, M.D. Research Psychiatrist
Organization
Depression Evaluation Service, New York State Psychiatric Institute
deliiyan@nyspi.columbia.edu
(212) 543-5734

Study Officials

  • Deborah Deliyannides, M.D.

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 26, 2007

Study Start

March 1, 2007

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

October 28, 2014

Results First Posted

October 28, 2014

Record last verified: 2013-05

Locations

US(1)