Trial Outcomes & Findings for Efficacy and Feasibility of a Personalized Treatment for Depression With Co-Occurring Anxiety (NCT NCT00930293)

NCT ID: NCT00930293

Last Updated: 2016-02-09

Results Overview

Depression remission defined as 3 consecutive weeks of HRSD-17 scores that on average, \< or = 7

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: Measured at baseline and weekly for up to 20 weeks of acute treatment
• Results posted on: 2016-02-09

Participant Flow

Participant milestones

Measure	Personalized Depression Care Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment. Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day	Standard Depression Care Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment. Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day
Overall Study STARTED	24	26
Overall Study COMPLETED	17	19
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Feasibility of a Personalized Treatment for Depression With Co-Occurring Anxiety

Baseline characteristics by cohort

Measure	Personalized Depression Care n=24 Participants Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment. Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day	Standard Depression Care n=26 Participants Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment. Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day	Total n=50 Participants Total of all reporting groups
Age, Continuous	30.37 years STANDARD_DEVIATION 11.41 • n=5 Participants	31.09 years STANDARD_DEVIATION 10.27 • n=7 Participants	30.74 years STANDARD_DEVIATION 10.72 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	26 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at baseline and weekly for up to 20 weeks of acute treatment

Depression remission defined as 3 consecutive weeks of HRSD-17 scores that on average, < or = 7

Outcome measures

Measure	Personalized Depression Care n=24 Participants Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment. Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day	Standard Depression Care n=26 Participants Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment. Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day
Number of Participants Meeting Depression Remission Criteria	10 participants	15 participants

SECONDARY outcome

Timeframe: Measured at baseline and weekly for up to 20 weeks of treatment

Kaplan-Meier survival analyses to determine time to depression remission (defined as average HRSD-17 score < or = 7 for three consecutive weeks).

Analyses run with the full intent to treat sample (censoring patients who dropped out at time of termination)

Outcome measures

Measure	Personalized Depression Care n=24 Participants Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment. Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day	Standard Depression Care n=26 Participants Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment. Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day
Weeks to Depression Remission	13.99 weeks Standard Error 1.47	11.59 weeks Standard Error 1.31

Adverse Events

Personalized Depression Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Depression Care

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Personalized Depression Care n=24 participants at risk Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment. Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day	Standard Depression Care n=26 participants at risk Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment. Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day
General disorders Unexplained Visual Disturbance	0.00% 0/24	3.8% 1/26 • Number of events 1

Additional Information

Jill M. Cyranowski, PhD

University of Pittsburgh

Phone: 412-246-5588

Email: cyranowskijm@upmc.edu

Results disclosure agreements

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