Trial Outcomes & Findings for A Pilot Study Assessing EmSam in Bipolar Depression (NCT NCT00535262)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

3 participants

Primary outcome timeframe

8 weeks

Results posted on

2014-10-28

Participant Flow

20 patients recruited from DES outpatient population with Bipolar Depression, ages 18-65.

Hypomania/mania requires treatment with mood stabilizer for at least two weeks; must be anti-depressant-free for two weeks (six weeks for fluoxetine.

Participant milestones

Participant milestones
Measure	EmSam 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. EmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	EmSam 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. EmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch
Overall Study No funding	3

Baseline Characteristics

A Pilot Study Assessing EmSam in Bipolar Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open EmSam n=3 Participants 8-week open-label treatment with EmSam
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome data not reported

Adverse Events

EmSam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Deborah A. Deliyannides, M.D. Research Psychiatrist

Depression Evaluation Service, New York State Psychiatric Institute

Phone: (212) 543-5734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place