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

Official Title: “Geriatric Depression: Getting Better, Getting Well”

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.

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

Intervention(s) in this Clinical Trial

• Drug: Escitalopram
  • Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks.
• Behavioral: Interpersonal Psychotherapy
  • 16 sessions of interpersonal psychotherapy (IPT)
• Behavioral: Clinical Monitoring
  • 16 weeks of depression care management(DCM). No psychotherapy will be provided.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 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)
• Active Comparator: 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)

Primary Measures

• Remission
  • Time Frame: Measured at Week 6 or 22
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Pittsburgh Other

Overall Clinical Trial Officials and Contacts

Charles F. Reynolds III, MD Principal Investigator University of Pittsburgh Professor of Psychiatry, Neurology, and Neuroscience  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00177294

Study ID Number: R01 MH037869-01

ClinicalTrials.gov Identifier: NCT00177294

Health Authority: United States: Federal Government

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