Dysthymia, Major Depressive Disorder
Conditions
Keywords
Depression
Brief summary
This study will recruit 100 depressed patients to test whether the previous finding of an association between treatment response (with treatment groups including placebo, imipramine, and fluoxetine) and preferences of hemispheric laterality in perceptual processing are also found with a different type of commonly used anti-depressant, bupropion.
Detailed description
Preliminary data suggest that depressed patients with increased left hemispheric laterality of perceptual processing are unlikely to improve during 6 weeks' treatment with placebo, while being very responsive to either imipramine or fluoxetine. Depressed patients who do not show evidence of poor right hemispheric functioning respond significantly more often to placebo than those with poor right hemispheric functioning , and do not show an advantage of drug over placebo. 100 patients will be tested with verbal and nonverbal dichotic tests, and then treated sequentially with bupropion, escitalopram, and imipramine. Preferential hemisphere for auditory processing will be correlated with treatment outcome.
Interventions
DRUGimipramine
imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted
DRUGescitalopram
Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d
DRUGbupropion
bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d
Sponsors
New York State Psychiatric Institute
Study design
Allocation
NON_RANDOMIZED
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 between 18-65 2. Meets Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) criteria for current Major Depression, Dysthymia or Depression Not Otherwise Specified
Exclusion criteria
1. Known Hearing impairment 2. Active suicidal ideation (history of suicide attempts will be evaluated on a case by case basis). 3. Hamilton Rating Scale for Depression (HAMD), 21-item total score \>20 4. Current (past 6 months)alcohol and/or drug abuse or dependence 5. Medical condition likely to require intervention contraindicated with study medication (e.g., known arrhythmia likely to be exacerbated by Imipramine) 6. Bipolar I 7. Psychosis 8. Non-response to adequate trial of study medication (i.e., \> or = 4 weeks on \> or = bupropion 300mg/d, escitalopram 30mg/d, or imipramine 200mg/d) 9. Premenopausal women not using known effective birth control 10. Not currently depressed (whether considered due to current treatment or not) 11. History of seizure, seizure disorder, anorexia nervosa, or bulimia 12. Left-handed -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Scale (HAM-D) | 6 weeks or last visit in Phase | Hamilton Depression Scale, 21 item version Summary of all 21 items and higher score means worse depression. Scores range from 0 to a maximum of 63. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression Scale (CGI) | 6 weeks or last visit in Phase | The CGI is a standard measure of global psychopathology. CGI-severity scores rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-improvement scores range from 1 (very much improved) through to 7 (very much worse). |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: 7/24/2006 - 4/7/2008 Recruitment Location: outpatient research clinic
Pre-assignment details
Patients had to have not taken psychotropic medication for at least two weeks (no fluoxetine for at least 5 weeks) and had to produce a urine negative for commonly abused substances. Current use of psychotropic medication or a positive urine toxicology screen would abort further study participation.
Participants by arm
| Arm | Count |
|---|---|
| Bupropion bupropion XL 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted
bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Phase I (Bupropion) | Adverse Event | 3 |
| Phase I (Bupropion) | Other | 1 |
| Phase II (Escitalopram) | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Bupropion |
|---|---|
| Age, Continuous | 36 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 11 | 10 / 17 | 3 / 3 |
| serious Total, serious adverse events | 0 / 11 | 1 / 17 | 0 / 3 |
Outcome results
Primary
Hamilton Depression Scale (HAM-D)
Hamilton Depression Scale, 21 item version Summary of all 21 items and higher score means worse depression. Scores range from 0 to a maximum of 63.
Time frame: 6 weeks or last visit in Phase
Population: Participants were included if they were given that medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupropion | Hamilton Depression Scale (HAM-D) | 11.2 units on a scale | Standard Deviation 7.9 |
| Escitalopram | Hamilton Depression Scale (HAM-D) | 9.7 units on a scale | Standard Deviation 6.4 |
| Imipramine | Hamilton Depression Scale (HAM-D) | 11.3 units on a scale | Standard Deviation 8.1 |
Secondary
Clinical Global Impression Scale (CGI)
The CGI is a standard measure of global psychopathology. CGI-severity scores rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-improvement scores range from 1 (very much improved) through to 7 (very much worse).
Time frame: 6 weeks or last visit in Phase
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupropion | Clinical Global Impression Scale (CGI) | 2.65 units on a scale | Standard Deviation 1.12 |
| Escitalopram | Clinical Global Impression Scale (CGI) | 2.73 units on a scale | Standard Deviation 1.1 |
| Imipramine | Clinical Global Impression Scale (CGI) | 2.67 units on a scale | Standard Deviation 0.58 |