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

Depression Clinical Trial

Official title:

Geriatric Depression: Getting Better, Getting Well

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177294
• Other study ID #: R01 MH037869-01
• Secondary ID: R01MH03786904040
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: January 10, 2012
• Start date: April 2004
• Est. completion date: August 2009

Study information

• Verified date: November 2010
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

For information on related studies, please follow these links:

http://clinicaltrials.gov/show/NCT00178035

http://clinicaltrials.gov/show/NCT00178074

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Reynolds CF 3rd, Dew MA, Martire LM, Miller MD, Cyranowski JM, Lenze E, Whyte EM, Mulsant BH, Pollock BG, Karp JF, Gildengers A, Szanto K, Dombrovski AY, Andreescu C, Butters MA, Morse JQ, Houck PR, Bensasi S, Mazumdar S, Stack JA, Frank E. Treating depre — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission	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.	Measured at Week 6 or 22	No