Trial Outcomes & Findings for Research Evaluating the Value of Augmenting Medication With Psychotherapy (NCT NCT00057551)

NCT ID: NCT00057551

Last Updated: 2017-12-06

Results Overview

Hamilton Depression Scale (HAM-D)\<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 491 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2017-12-06

Participant Flow

Participant milestones

Measure	CBASP Cognitive Behavioral Analysis System of Psychotherapy	BriefSP Brief Supportive Psychotherapy	Medication Only An algorithm including Sertraline, Escitalopram Bupropion SR or XL Venlafaxine XR Mirtazapine
Overall Study STARTED	200	195	96
Overall Study COMPLETED	175	168	80
Overall Study NOT COMPLETED	25	27	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Research Evaluating the Value of Augmenting Medication With Psychotherapy

Baseline characteristics by cohort

Measure	CBASP n=200 Participants Cognitive Behavioral Analysis System of Psychotherapy	Brief Supportive P n=195 Participants Brief Supportive Psychotherapyherapy	Medication Only n=96 Participants Sertraline Escitalopram Bupropion SR or XL Venlafaxine XR Mirtazapine	Total n=491 Participants Total of all reporting groups
Age, Continuous	43.2 years STANDARD_DEVIATION 13.4 • n=5 Participants	46.4 years STANDARD_DEVIATION 11.7 • n=7 Participants	45.3 years STANDARD_DEVIATION 11.9 • n=5 Participants	45.9 years STANDARD_DEVIATION 11.8 • n=4 Participants
Sex: Female, Male Female	112 Participants n=5 Participants	113 Participants n=7 Participants	47 Participants n=5 Participants	272 Participants n=4 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	82 Participants n=7 Participants	49 Participants n=5 Participants	219 Participants n=4 Participants
Region of Enrollment United States	200 participants n=5 Participants	195 participants n=7 Participants	96 participants n=5 Participants	491 participants n=4 Participants
Hamilton Depression Scale	19.52 units on a scale STANDARD_DEVIATION 8.26 • n=5 Participants	19.44 units on a scale STANDARD_DEVIATION 8.31 • n=7 Participants	18.4 units on a scale STANDARD_DEVIATION 8.8 • n=5 Participants	19.48 units on a scale STANDARD_DEVIATION 8.27 • n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Refers to # of subjects who completed 12 weeks of treatment

Hamilton Depression Scale (HAM-D)<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits

Outcome measures

Measure	CBASP n=174 Participants Cognitive Behavioral Analysis System of Psychotherapy	Brief SP n=168 Participants Supportive Therapy	Medication Only n=76 Participants Sertraline Escitalopram Bupropion SR or XL Venlafaxine XR Mirtazapine
Remission	38.5 percentage of participants	31.0 percentage of participants	39.5 percentage of participants

Adverse Events

CBASP

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

BriefSP

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Medication

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	CBASP n=200 participants at risk Cognitive Behavioral Analysis System of Psychotherapy	BriefSP n=195 participants at risk Supportive Therapy	Medication n=96 participants at risk Sertraline Escitalopram Bupropion SR or XL Venlafaxine XR Mirtazapine
Psychiatric disorders moderate burden	14.0% 28/200 • Number of events 28	11.8% 23/195	8.3% 8/96 • Number of events 8

Additional Information

James H. Kocsis, M.D.

Weill Cornell Medical College

Phone: 212-746-5913

Email: jhk2002@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place