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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: August 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Escitalopram
  • Participants will take 10 mg escitalopram for first 6 weeks and, if inadequate response to treatment, will be randomized to 20 mg escitalopram for 16 additional weeks.
• Behavioral: Interpersonal Psychotherapy
  • IPT includes 16 sessions of psychotherapy used to reduce lingering symptoms of depression and to decrease the burden of these symptoms.
• Drug: Clinical Monitoring
  • Participants will receive 16 weeks of standard clinical monitoring. No psychotherapy will be provided.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Participants who are partial responders to escitalopram in first 6 weeks of treatment and receive 16 weeks of extension therapy with escitalopram 20 mg, plus interpersonal psychotherapy (IPT)
• Active Comparator: 2
  • Participants who receive 16 weeks of extension therapy with escitalopram 20 mg plus medication clinical monitoring with no psychotherapy

Primary Measures

• Combined treatment (escitalopram plus IPT) will lead to higher response and remission rates, and greater absolute improvement in Hamilton Rating Scale for Depression scores (administered weekly) over time, than escitalopram monotherapy
  • Time Frame: Measured at Week 6 or 22
    Safety Issue?: No

Secondary Measures

• Partial responders to escitalopram monotherapy will be characterized, at baseline, by higher rates of hopelessness (BHS) and suicidal ideation (Beck Scale for SI), greater levels of disability (MOS-SF) and cognitive impairment (MMSE, EXIT, MDRS).
  • Time Frame: Measured at Week 6 or 22
    Safety Issue?: No

Inclusion Criteria:

• Diagnosis of unipolar major 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
• 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 Sponsor: National Institute of Mental Health (NIMH)

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 August 28, 2008

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

Study ID Number: R01 MH37869

ClinicalTrials.gov Identifier: NCT00177294

Health Authority: United States: Federal Government

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