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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00177294
First Posted: September 15, 2005
Last Update Posted: January 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pittsburgh
  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
Intervention Model: Parallel Assignment
Masking: Single (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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00177294


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

Publications:
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: R01MH037869-01 ( U.S. NIH Grant/Contract )
R01MH037869 ( U.S. NIH Grant/Contract )
0404007
DATR A4-GPS
First Submitted: September 12, 2005
First Posted: September 15, 2005
Results First Submitted: December 22, 2010
Results First Posted: March 15, 2011
Last Update Posted: January 12, 2012
Last Verified: November 2010

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

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