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Completed

NCT Number: NCT00177294

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Escitalopram

Drug

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

Other names: Lexapro

interpersonal psychotherapy

Behavioral

16 sessions of interpersonal psychotherapy (IPT)

Other names: IPT

Clinical Monitoring

Behavioral

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

Primary outcomes

  1. Remission

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Geriatric Depression: Getting Better, Getting Well

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 15, 2005
Registry last updated
Jan 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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