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Trial Outcomes & Findings for Treatments for Depression: Drug Versus Psychotherapy (NCT NCT00043550)

NCT ID: NCT00043550

Last Updated: 2017-06-02

Results Overview

Hamilton Rating Scale for Depression (HRSD) (Hamilton, 1960). We used the 17-item version of the 27-item HRSD, a measure of depression severity. The Structured Interview Guide was used to conduct the interviews (SIGH-D; Williams, 1988). The reliability and validity of the HRSD are well documented (Rabkin \& Klein, 1987). Interjudge reliability as assessed by interclass correlations was .92 in our sample. Total 17-item scores could range from 17-48 with higher scores indicating greater distress.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

156 participants

Primary outcome timeframe

symptoms assessed during past 7 days, measure taken at baseline, week 8 and week 16

Results posted on

2017-06-02

Participant Flow

374 individuals, ages 18 to 70 years, were recruited through advertisements on public transportation, free news publications, area physicians, and outpatient clinics during the period of 2001-2006.

Individuals not meeting MDD diagnostic criteria11 using the Structured Clinical Interviews for DSM-IV12 or scoring less than 14 on the 17-item Hamilton Rating Scale for Depression (HRSD)13,14 at two evaluations one week apart were excluded (n=88).

Participant milestones

Participant milestones
Measure
1 Sertraline
Participants receive sertraline. Sertraline : Participants will receive sertraline.
2 Supportive-expressive Psychotherapy
Participants will receive supportive-expressive psychotherapy. Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.
3 Pill Placebo
Participants receive placebo. Pill Placebo : Participants will receive a pill placebo.
Overall Study
STARTED
55
51
50
Overall Study
Week 8 Completed
35
40
35
Overall Study
COMPLETED
33
39
30
Overall Study
NOT COMPLETED
22
12
20

Reasons for withdrawal

Reasons for withdrawal
Measure
1 Sertraline
Participants receive sertraline. Sertraline : Participants will receive sertraline.
2 Supportive-expressive Psychotherapy
Participants will receive supportive-expressive psychotherapy. Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.
3 Pill Placebo
Participants receive placebo. Pill Placebo : Participants will receive a pill placebo.
Overall Study
Withdrawal by Subject
22
12
20

Baseline Characteristics

Treatments for Depression: Drug Versus Psychotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
1 Sertraline
n=55 Participants
Participants receive sertraline. Sertraline : Participants will receive sertraline.
2 Supportive-expressive Psychotherapy
n=51 Participants
Participants will receive supportive-expressive psychotherapy. Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.
3 Pill Placebo
n=50 Participants
Participants receive placebo. Pill Placebo : Participants will receive a pill placebo.
Total
n=156 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
55 Participants
n=5 Participants
51 Participants
n=7 Participants
50 Participants
n=5 Participants
156 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
38.0 years
STANDARD_DEVIATION 12.5 • n=5 Participants
36.2 years
STANDARD_DEVIATION 12.2 • n=7 Participants
38.3 years
STANDARD_DEVIATION 12.0 • n=5 Participants
37.5 years
STANDARD_DEVIATION 12.2 • n=4 Participants
Sex: Female, Male
Female
30 Participants
n=5 Participants
31 Participants
n=7 Participants
31 Participants
n=5 Participants
92 Participants
n=4 Participants
Sex: Female, Male
Male
25 Participants
n=5 Participants
20 Participants
n=7 Participants
19 Participants
n=5 Participants
64 Participants
n=4 Participants
Region of Enrollment
United States
55 participants
n=5 Participants
51 participants
n=7 Participants
50 participants
n=5 Participants
156 participants
n=4 Participants

PRIMARY outcome

Timeframe: symptoms assessed during past 7 days, measure taken at baseline, week 8 and week 16

Population: Numbers vary from consented due to dropout prior to start of study. 156 patients consented and randomized. 11 patients did not complete at least one post-randomization measure and were therefore not included in these analyses.

Hamilton Rating Scale for Depression (HRSD) (Hamilton, 1960). We used the 17-item version of the 27-item HRSD, a measure of depression severity. The Structured Interview Guide was used to conduct the interviews (SIGH-D; Williams, 1988). The reliability and validity of the HRSD are well documented (Rabkin \& Klein, 1987). Interjudge reliability as assessed by interclass correlations was .92 in our sample. Total 17-item scores could range from 17-48 with higher scores indicating greater distress.

Outcome measures

Outcome measures
Measure
1 Sertraline
n=51 Participants
Participants receive sertraline. Sertraline : Participants will receive sertraline.
2 Supportive-expressive Psychotherapy
n=46 Participants
Participants will receive supportive-expressive psychotherapy. Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.
3 Pill Placebo
n=48 Participants
Participants receive placebo. Pill Placebo : Participants will receive a pill placebo.
Hamilton Rating Scale for Depression-17 Item
Initial HRSD-17
19.0 units on a scale
Standard Deviation 3.4
19.9 units on a scale
Standard Deviation 3.9
19.4 units on a scale
Standard Deviation 3.7
Hamilton Rating Scale for Depression-17 Item
Mid-treatment HRSD-17
13.9 units on a scale
Standard Deviation 7.2
12.5 units on a scale
Standard Deviation 6.9
12.7 units on a scale
Standard Deviation 6.8
Hamilton Rating Scale for Depression-17 Item
LOCF HRSD-17
14.2 units on a scale
Standard Deviation 7.6
14.5 units on a scale
Standard Deviation 8.3
14.3 units on a scale
Standard Deviation 7.6

Adverse Events

1 Sertraline

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

2 Supportive-expressive Psychotherapy

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

3 Pill Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
1 Sertraline
n=55 participants at risk
Participants receive sertraline. Sertraline : Participants will receive sertraline.
2 Supportive-expressive Psychotherapy
n=51 participants at risk
Participants will receive supportive-expressive psychotherapy. Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.
3 Pill Placebo
n=50 participants at risk
Participants receive placebo. Pill Placebo : Participants will receive a pill placebo.
Psychiatric disorders
passive suicide attempt
0.00%
0/55
2.0%
1/51 • Number of events 1
0.00%
0/50

Additional Information

Jacques P.Barber, PhD, Dean and Professor

Adelphi University, The Derner Institute of Advanced Psychological Studies

Phone: 516.877.4807

Results disclosure agreements

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