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

Phase 4

Completed

Conditions: Depression

Interventions: Drug: Escitalopram
Behavioral: Interpersonal Psychotherapy
Behavioral: Clinical Monitoring

Registration Number: NCT00177294

Lead Sponsor: University of Pittsburgh

Brief Summary: This study will determine whether adding interpersonal psychotherapy to treatment with the antidepressant escitalopram will be more effective in reducing symptoms of depression than antidepressant medication alone.

Detailed Description: The purpose of this research study is to learn if adding psychotherapy (Interpersonal Psychotherapy) to antidepressant medication (escitalopram), will be more effective in reducing lingering symptoms of depression and decreasing the burden of these symptoms, when initial treatment with just antidepressant medication alone has led to only a partial response. Participation in the study will last up to 22 weeks.

Because fewer than 50% of elderly depressed patients achieve remission and recovery in response to first-line antidepressant pharmacotherapy, the majority of patients are left with significant symptoms and functional impairment, putting them at risk of chronic, relapsing illness, non-adherence to other medical treatment, suicide, and family caregiver burden. We will recruit and treat 320 patients with unipolar major depression aged 60 and older, using clinical management with escitalopram 10 mg/day for six weeks. Patients who are partial responders to escitalopram plus clinical management will be randomly assigned to 16 weeks of extension therapy with either 20 mg escitalopram plus clinical management or 20 mg escitalopram plus Interpersonal Psychotherapy (IPT, 16 sessions). Changes over time in measures of depressive symptoms, hopelessness, suicidal ideation, disability, and family caregiving burden will be assessed. This study will answer the question of how best to treat partial responders-by simply extending pharmacotherapy at higher doses, or by also adding psychotherapy-to remission and recovery.

For information on related studies, please follow these links:

http://clinicaltrials.gov/show/NCT00178035

http://clinicaltrials.gov/show/NCT00178074

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 319

Inclusion Criteria

Diagnosis of unipolar major depression
Hamilton Rating Scale for Depression (HRSD) (17 item) score of 15 or higher
Speaks English
Willing to discontinue other psychotropic medications
Availability of family member or other caregiver
Hearing capacity adequate to respond to a raised conversational voice

Exclusion Criteria

Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or any psychotic disorder
Folstein Mini-Mental Status Exam (MMSE) of 17 or lower
Suicidal
History of treatment non-adherence in other Center protocols
History of documented non-response to citalopram in other Center protocols
History of non-tolerance to escitalopram therapy

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Interpersonal Psychotherapy	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)
1	Escitalopram	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)
2	Clinical Monitoring	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(DCM) without interpersonal psychotherapy (IPT)
2	Escitalopram	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(DCM) without interpersonal psychotherapy (IPT)

Primary Outcome Measures

Name	Time	Method
Remission	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.

Secondary Outcome Measures