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Factors of Treatment Response in Major Depressive Disorder
This study will use measurements of depression symptoms and brain activity to determine what factors may influence an individual's response to treatment for depression.
Details
| Lead sponsor | University of California, Los Angeles |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 88 |
| Start date | 2005-08 |
| Completion | 2009-06 |
Conditions
- Depression
Interventions
- Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro)
- Placebo
- Interpersonal Clinical Interaction (ICI)
Primary outcomes
- Response as Assessed by Participants' Change in Depression Rating — Baseline, Week 8
Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale (HAM-D-17) used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.Response is defined as a 50% decrease in HAMD-17 scoring. Remission defined as a HAMD-17 score of 7 or less. - Average Change in 3 Weeks of Participant Treatment Expectations — Averaged over 3 time points (Baseline, randomization, and end of lead-in)
Patient Attitudes and Expectations Form used for assessing expectation. The California Pharmacotherapy Alliance Scale, a measure associated with outcomes of antidepressant pharmacotherapy, used to measure participants' perceptions of: (a) participants' commitment to treatment; (b) participants' working capacity; (c) treatment providers' understanding and involvement; and (d) goal and working strategy consensus between participant and treatment provider. This is a 24-item questionnaire with a 7-point Likert scale (1 = not at all, 7 = very much so). Total score ranges from a minimum of 0 and a maximum of 120. The score is determined by a combination of negative and positive items. To assure negative items are reflected, subtract each of the negative item ratings from 8; for example, a rating of 1 becomes 7 (8 minus 1). The scores are computed by summing the items and dividing the total by 6 to procure the mean rating. A lower score indicates a worse outcome. - Change in Hamilton Depression Assessment Score — Baseline,Week 8
Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression/worse outcome. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.
Countries
United States