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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177294
First received: September 12, 2005
Last updated: January 10, 2012
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Depression
Drug: Escitalopram
Behavioral: Interpersonal Psychotherapy
Behavioral: Clinical Monitoring
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Geriatric Depression: Getting Better, Getting Well

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Remission [ Time Frame: Measured at Week 6 or 22 ] [ Designated as safety issue: No ]
    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.


Enrollment: 319
Study Start Date: April 2004
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: Escitalopram
Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks.
Other Name: Lexapro
Behavioral: Interpersonal Psychotherapy
16 sessions of interpersonal psychotherapy (IPT)
Other Name: 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)
Drug: Escitalopram
Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks.
Other Name: Lexapro
Behavioral: Clinical Monitoring
16 weeks of depression care management(DCM). No psychotherapy will be provided.

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.

For information on related studies, please follow these links:

http://clinicaltrials.gov/show/NCT00178035

http://clinicaltrials.gov/show/NCT00178074

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177294

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Charles F. Reynolds III, MD University of Pittsburgh Professor of Psychiatry, Neurology, and Neuroscience
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177294     History of Changes
Other Study ID Numbers: R01 MH037869-01, R01MH037869, 0404007, DATR A4-GPS
Study First Received: September 12, 2005
Results First Received: December 22, 2010
Last Updated: January 10, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Elderly
Remission
Escitalopram
Interpersonal Psychotherapy
Psychotherapy
Caregiving
Late-Life

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014