Trial Outcomes & Findings for Evaluation of Depression Symptoms and Brain Activity Associated With Response to Treatment of Depression (NCT NCT00200902)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

88 participants

Primary outcome timeframe

Baseline, Week 8

Results posted on

2024-08-13

Participant Flow

133 subjects were screened for eligibility and 88 were eligible for enrollment between 8/19/05 - 8/7/08 at the UCLA Laboratory of Brain, Behavior, and Pharmacology. 88 participants were randomized however, n=67 for many of the measures as subjects who did not complete the Week 8 visit were not included in the analysis.

Subjects were required to wash out of any other antidepressant medications for one week (30 days if washing out from fluoxetine).

Participant milestones

Participant milestones
Measure	MEDS + ICI MED 1-venlafaxine XR, MED 2-Duloxetine (Cymbalta), MED 3-Escitalopram (Lexapro)	Placebo+ICI	ICI Alone Subjects assigned to the interpersonal clinical interaction (ICI). Visits will involve a session with a research nurse that will be approximately 20 minutes in length; visits at baseline, end of lead-in, and 1, 2, 4, and 8 weeks also will include a brief (5-10 minutes) meeting with a physician.
Overall Study STARTED	39	29	20
Overall Study COMPLETED	29	26	12
Overall Study NOT COMPLETED	10	3	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Depression Symptoms and Brain Activity Associated With Response to Treatment of Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Medication Treatment (MED) n=39 Participants MED 1-venlafaxine XR, MED 2-Duloxetine (Cymbalta), MED 3-Escitalopram (Lexapro)	Placebo n=29 Participants	Interpersonal Clinical Interaction n=20 Participants Subjects assigned to the interpersonal clinical interaction (ICI). Visits involve a session with a research nurse that will be approximately 20 minutes in length; visits at baseline, end of lead-in, and 1, 2, 4, and 8 weeks also will include a brief (5-10 minutes) meeting with a physician.	Total n=88 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants	29 Participants n=7 Participants	20 Participants n=5 Participants	88 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	41.67 years STANDARD_DEVIATION 13.63 • n=5 Participants	41.75 years STANDARD_DEVIATION 14.35 • n=7 Participants	43.1 years STANDARD_DEVIATION 12.7 • n=5 Participants	41.96 years STANDARD_DEVIATION 13.74 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	18 Participants n=7 Participants	12 Participants n=5 Participants	55 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	33 Participants n=4 Participants
Region of Enrollment United States	29 participants n=5 Participants	26 participants n=7 Participants	12 participants n=5 Participants	67 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: Participants completing the Week 8 visit were included in the analysis (n=67)

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.

Outcome measures

Outcome measures
Measure	MEDICATIONS n=29 Participants Three different types of medications were utilized and assigned specifically to each subject depending on their condition. Interpersonal clinical interaction (ICI) plus clinically assigned medication (Venlafaxine XR, Duloxetine, or Escitalopram).	Placebo (PBO) n=26 Participants Interpersonal clinical interaction (ICI) plus placebo	Interpersonal Clinical Interaction (ICI) n=12 Participants Interpersonal clinical interaction (ICI) ONLY
Response as Assessed by Participants' Change in Depression Rating Responders	17 Participants	11 Participants	1 Participants
Response as Assessed by Participants' Change in Depression Rating Remitters	9 Participants	9 Participants	0 Participants

PRIMARY outcome

Timeframe: Averaged over 3 time points (Baseline, randomization, and end of lead-in)

Population: 88 participants who completed the first 3 time points in the study

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.

Outcome measures

Outcome measures
Measure	MEDICATIONS n=39 Participants Three different types of medications were utilized and assigned specifically to each subject depending on their condition. Interpersonal clinical interaction (ICI) plus clinically assigned medication (Venlafaxine XR, Duloxetine, or Escitalopram).	Placebo (PBO) n=29 Participants Interpersonal clinical interaction (ICI) plus placebo	Interpersonal Clinical Interaction (ICI) n=20 Participants Interpersonal clinical interaction (ICI) ONLY
Average Change in 3 Weeks of Participant Treatment Expectations	3.55 units on a scale Standard Deviation .78	3.94 units on a scale Standard Deviation .61	3.17 units on a scale Standard Deviation 1.16

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MEDICATIONS n=29 Participants Three different types of medications were utilized and assigned specifically to each subject depending on their condition. Interpersonal clinical interaction (ICI) plus clinically assigned medication (Venlafaxine XR, Duloxetine, or Escitalopram).	Placebo (PBO) n=26 Participants Interpersonal clinical interaction (ICI) plus placebo	Interpersonal Clinical Interaction (ICI) n=12 Participants Interpersonal clinical interaction (ICI) ONLY
Change in Hamilton Depression Assessment Score Percent Change in HAM-D	-0.46 HAMD score Standard Deviation 0.31	-0.36 HAMD score Standard Deviation 0.39	-0.05 HAMD score Standard Deviation 0.27
Change in Hamilton Depression Assessment Score Change in HAM-D	-10.05 HAMD score Standard Deviation 6.60	-7.59 HAMD score Standard Deviation 7.98	-1.37 HAMD score Standard Deviation 5.27

Adverse Events

Medication

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo (PBO)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Interpersonal Clinical Interaction (ICI)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrew Leuchter, MD

Laboratory of Brain, Behavior, and Pharmacology at the University of California Los Angeles

Phone: 310-825-0207

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place