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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

319 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of Depression in Adults

NCT00073697

Depression

COMPLETED PHASE4

Depression: The Search for Treatment-Relevant Phenotypes-Pilot Study

NCT00222820

Major Depression

COMPLETED PHASE4

Mechanisms of Antidepressant Non-Response in Late-Life Depression

NCT01931202

Major Depressive Disorder

COMPLETED NA

Effects Of Antidepressants On Sexual Functioning In Adults

NCT00051272

Major Depressive Disorder (MDD)

COMPLETED PHASE3

Testing the Effectiveness of Cognitive Training Among Depressed Patients Receiving Esketamine Treatment

NCT05719909

Depression

SUSPENDED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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)

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks.

Interpersonal Psychotherapy

Intervention Type BEHAVIORAL

16 sessions of interpersonal psychotherapy (IPT)

2

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)

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks.

Clinical Monitoring

Intervention Type BEHAVIORAL

16 weeks of depression care management(DCM). No psychotherapy will be provided.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Escitalopram

Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks.

Intervention Type DRUG

Interpersonal Psychotherapy

16 sessions of interpersonal psychotherapy (IPT)

Intervention Type BEHAVIORAL

Clinical Monitoring

16 weeks of depression care management(DCM). No psychotherapy will be provided.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lexapro IPT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No