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

Condition(s) targeted: Depression

Intervention: Escitalopram (Drug); Interpersonal Psychotherapy (Behavioral); Clinical Monitoring (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: National Institute of Mental Health (NIMH)

Official(s) and/or principal investigator(s):
Charles F. Reynolds III, MD, Principal Investigator, Affiliation: University of Pittsburgh Professor of Psychiatry, Neurology, and Neuroscience

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.

Official title: Geriatric Depression: Getting Better, Getting Well

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

Primary outcome: 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

Secondary outcome: 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).

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.

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States

An online resource for older individuals with mental health problems and their families.

Starting date: April 2004
Ending date: August 2009
Last updated: March 3, 2008