Trial Outcomes & Findings for Augmenting Antidepressant Treatment With Interpersonal Psychotherapy for Treating Late-life Depression (NCT NCT00177294)

NCT ID: NCT00177294

Last Updated: 2012-01-12

Results Overview

Three consecutive weekly scores of less than 7 on the Hamilton Rating Scale for Depression (N=17 item). Scores on the Hamilton Rating Scale for Depression(HRSD) range from 0 to 58, with higher scores indicating more severe depression.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 319 participants
• Primary outcome timeframe: Measured at Week 6 or 22
• Results posted on: 2012-01-12

Participant Flow

Participants were recruited from primary care and specialty mental-health clinics. 377 participants signed consent; 319 started study treatment; 124 were randomized. Of the 124 participants, 60 were randomized to Interpersonal Psychotherapy (IPT) and 59 randomized to Depression Care Management(DCM) without IPT.

67 enrolled participants were not randomized due to the following reasons: consent withdrawal (41); did not meet eligibility criteria (16); supervening medical problems that precluded participation (4); past history of non-reponse to escitalopram (1); side effects (1).

Participant milestones

Measure	Escitalopram Plus Interpersonal Psychotherapy (IPT) Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)	Escitalopram Plus Depression Care Management (DCM) Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
Overall Study STARTED	60	64
Overall Study COMPLETED	53	59
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Measure	Escitalopram Plus Interpersonal Psychotherapy (IPT) Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)	Escitalopram Plus Depression Care Management (DCM) Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
Overall Study Withdrawal by Subject	7	5

Baseline Characteristics

Augmenting Antidepressant Treatment With Interpersonal Psychotherapy for Treating Late-life Depression

Baseline characteristics by cohort

Measure	Escitalopram Plus Interpersonal Psychotherapy (IPT) n=60 Participants Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)	Escitalopram Plus Depression Care Management (DCM) n=64 Participants Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)	Total n=124 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
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	49 Participants n=5 Participants	55 Participants n=7 Participants	104 Participants n=5 Participants
Age Continuous	71.1 years STANDARD_DEVIATION 7.1 • n=5 Participants	73.4 years STANDARD_DEVIATION 7.7 • n=7 Participants	72.27 years STANDARD_DEVIATION 7.51 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	41 Participants n=7 Participants	85 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	23 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants	64 participants n=7 Participants	124 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at Week 6 or 22

Three consecutive weekly scores of less than 7 on the Hamilton Rating Scale for Depression (N=17 item). Scores on the Hamilton Rating Scale for Depression(HRSD) range from 0 to 58, with higher scores indicating more severe depression.

Outcome measures

Measure	Escitalopram Plus Interpersonal Psychotherapy (IPT) n=60 Participants Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)	Escitalopram Plus Depression Care Management (DCM) n=64 Participants Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
Remission	58 Percentage of participants Interval 46.0 to 71.0	45 Percentage of participants Interval 33.0 to 58.0

Adverse Events

Escitalopram Plus Interpersonal Psychotherapy (IPT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Escitalopram Plus Depression Care Management (DCM)

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

Charles F. Reynolds III, MD

University of Pittsburgh

Phone: 412-246-6414

Email: reynoldscf@upmc.edu

Results disclosure agreements

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