Does Dual Therapy Hasten Antidepressant Response?
|ClinicalTrials.gov Identifier: NCT00519428|
Recruitment Status : Completed
First Posted : August 22, 2007
Results First Posted : October 4, 2017
Last Update Posted : October 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: escitalopram Drug: bupropion extra long (XL) Drug: escitalopram + bupropion||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||245 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Combining Antidepressants to Hasten Remission From Depression|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||March 2012|
Experimental: escitalopram + bupropion
escitalopram plus bupropion extra long (XL) as dual treatment (i.e., this is not a SINGLE treatment arm; all patients assigned this arm received both medications)
Drug: escitalopram + bupropion
same dosing schedule as for monotherapy
Active Comparator: escitalopram
10mg/d increasing by 10 mg/week to a maximum of 40 mg/d if tolerated and not remitted
Other Name: Lexapro
Active Comparator: bupropion
bupropion extra long (XL) monotherapy
Drug: bupropion extra long (XL)
150mg/d increasing to 300 mg/d after 1 week and 450 mg/d after 3 weeks, all increases if tolerated and not remitted
Other Name: Wellbutrin extra long (XL)
- Time to Remission, Defined by the Week of Onset of Persistent Hamilton Rating Scale for Depression (HAM-D 17) <= 7, With no Subsequent HAM-D 17 > 7 [ Time Frame: 12 weeks ]Life Table Survival Analysis run twice, once comparing Dual Therapy (i.e., Bupropion + Escitalopram) to Bupropion alone (i.e., Bupropion + Placebo) and once comparing Dual Therapy to Escitalopram alone (i.e., Escitalopram + Placebo). Because both analyses must significantly favor Dual Therapy, each individual analysis must reach a critical alpha = .0916 in order to reach an over-all alpha = .05.
- Remission: Persistent Hamilton Rating Scale for Depression, 17 Items (HAM-D 17) <= 7, With no HAM-D 17 >7 Through Week 12 [ Time Frame: 12 weeks ]Chi square comparison of rates of persistent remission (i.e., no subsequent Hamilton Rating Scale for Depression, 17 items [HAMD-D 17] > 7 once HAMD-D 17 <= 7); Dual rate vs. Escitalopram only rate and Dual rate vs. Bupropion only rate.
- Severity of Depressive Symptoms as Measured by Hamilton Rating Scale for Depression (HAM-D 17) [ Time Frame: 12 weeks ]
Last summary score rating on the 17-item Hamilton Rating Scale for Depression Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Range 0-58.
0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression
≥ 23 = Very Severe Depression
- Functioning, as Measured by the Social Adjustment Scale (SAS) Summary Score [ Time Frame: 12 weeks ]Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning
- Quality of Life, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form (SF) [ Time Frame: 12 weeks ]
The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) intends to measure quality of life in 16 domains. A summary score is computed by adding the scores and dividing by 16 (or the number of answered items if some are not answered).
The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Higher score means more satisfaction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519428
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|University of Ottawa, Institute of Mental Health Research|
|Ottawa, Ontario, Canada, K1Z7K4|
|Principal Investigator:||Jonathan W. Stewart, M.D.||New York State Psychiatric Institute|
|Principal Investigator:||Pierre Blier, M.D.||University of Ottawa, Institute of Mental Health Research|