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

NCT00177294 | Completed Phase 4 Results DMC

• 4 other identifiers: R01MH037869-01R01MH0378690404007DATR A4-GPS
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

Elderly; Remission; Escitalopram; Interpersonal Psychotherapy; Psychotherapy; Caregiving; Late-Life

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

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)

Drug: Escitalopram; Behavioral: Interpersonal Psychotherapy

2

ACTIVE COMPARATOR

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)

Drug: Escitalopram; Behavioral: Clinical Monitoring

Interventions

Escitalopram DRUG

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

Also known as: Lexapro

1; 2

Interpersonal Psychotherapy BEHAVIORAL

16 sessions of interpersonal psychotherapy (IPT)

Also known as: IPT

1

Clinical Monitoring BEHAVIORAL

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

2

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• 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 depression to remission in older adults: a controlled evaluation of combined escitalopram with interpersonal psychotherapy versus escitalopram with depression care management. Int J Geriatr Psychiatry. 2010 Nov;25(11):1134-41. doi: 10.1002/gps.2443.

  PMID: 20957693 RESULT

• Andreescu C, Tudorascu DL, Butters MA, Tamburo E, Patel M, Price J, Karp JF, Reynolds CF 3rd, Aizenstein H. Resting state functional connectivity and treatment response in late-life depression. Psychiatry Res. 2013 Dec 30;214(3):313-21. doi: 10.1016/j.pscychresns.2013.08.007. Epub 2013 Oct 18.

  PMID: 24144505 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Escitalopram; Interpersonal Psychotherapy; Clinical Trials Data Monitoring Committees

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Psychotherapy; Behavioral Disciplines and Activities; Professional Staff Committees; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation

Limitations and Caveats

The study design does not allow an inference about which specific intervention led to further improvement. Was it simply a dose increase of escitalopram from 10mg to 20mg? Is this intensive contact necessary for improvement?

Results Point of Contact

• Title: Charles F. Reynolds III, MD
• Organization: University of Pittsburgh

reynoldscf@upmc.edu

412-246-6414

Study Officials

• Charles F. Reynolds III, MD

  University of Pittsburgh Professor of Psychiatry, Neurology, and Neuroscience

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: April 1, 2004
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: January 12, 2012
• Results First Posted: March 15, 2011

Record last verified: 2010-11

Locations

US (1)