Bipolar Depression
Conditions
Keywords
Bipolar, depression
Brief summary
This pilot study will evaluate the efficacy of the monoamine oxidase inhibitor (MAOI)EmSam, a selegiline transdermal system (STS), in bipolar depression.
Detailed description
Most current treatments for bipolar depression have been shown to be of modest effectiveness. There is some literature which suggests that Monoamine Oxidase Inhibitors (MAOIs) have greater efficacy than tricyclic antidepressants, and that they are effective for treatment-resistant depression of all types, both unipolar and bipolar. The MAOI selegiline has demonstrated antidepressant efficacy. EmSam, a selegiline transdermal system, provides central nervous system but not intestinal/liver MAO inhibition without clinically significant increases in sensitivity to dietary tyramine. This transdermal system appears to be associated with fewer side effects and increased safety relative to oral MAOI's. This pilot study will evaluate the efficacy of EmSam in bipolar depression.
Interventions
DRUGEmSam
Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch
Sponsors
New York State Psychiatric Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Ages 18 - 65 2. DSM-IV Bipolar Disorder (I, II, NOS), Depressed Phase 3. 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). 4. Prior failure of or inability to tolerate at least one other antidepressant treatment 5. Physically healthy 6. Agrees to participate in the study 7. HAM-D 24 \> 10
Exclusion criteria
1. Bipolar Disorder (I, II, NOS), Mixed State without adequate mood stabilization 2. Prior significant adverse reaction to EmSam 3. Unstable medical disorder 4. History of epilepsy (febrile seizure o.k.) 5. Current use of any medication that might interact with EnSam. 6. Use within 2 weeks of other antidepressant medication (6 weeks for fluoxetine) 7. Inability to adhere to a tyramine-free diet 8. Recent (past 6 months) suicide attempt 9. Serious suicidal ideation 10. Pregnant 11. Breast feeding 12. Fecund, sexually active females, without adequate contraception 13. Prior failure to respond to 2 or more adequate oral MAOI trials (2/3 PDR maximum dose, minimum 4 weeks) 14. Non-nicotine substance abuse/dependence within the past 6 months (1 year for amphetamines/cocaine)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Depression CGI Score (<= 2) | 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. |
Countries
United States
Participant flow
Recruitment details
20 patients recruited from DES outpatient population with Bipolar Depression, ages 18-65.
Pre-assignment details
Hypomania/mania requires treatment with mood stabilizer for at least two weeks; must be anti-depressant-free for two weeks (six weeks for fluoxetine.
Participants by arm
| Arm | Count |
|---|---|
| Open EmSam 8-week open-label treatment with EmSam | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No funding | 3 |
Baseline characteristics
| Characteristic | Open EmSam |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
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.
Time frame: 8 weeks