Bipolar Disorder I or II
Conditions
Keywords
Major Depressive Episode, Depression NOS, Bipolar Disorder, Bipolar Disorder I, Bipolar Disorder II, Bipolar Depression, Major Depression
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.
Interventions
DRUGTranylcypromine
Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study
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. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tranylcypromine Active, open-label tranylcypromine treatment
Tranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Switched to follow-up phase | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Tranylcypromine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 41 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 7 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
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.
Time frame: Hamilton 29 score at baseline (start date of medication) and week 16
Population: 2 patients who did not make it to week 16 (one dropped out at week 3 and one dropped out at week 9)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tranylcypromine | 29 Item Hamilton Rating Scale for Depression (HamD29) | Baseline Score | 27.0 Hamilton Depression score | Standard Error 1.4 |
| Tranylcypromine | 29 Item Hamilton Rating Scale for Depression (HamD29) | Week 16 Score | 5.8 Hamilton Depression score | Standard Error 2.1 |