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

September 12, 2005
January 10, 2012
April 2004
August 2009   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT00177294 on ClinicalTrials.gov Archive Site
Not Provided
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).
Not Provided
Not Provided
 
Augmenting Antidepressant Treatment With Interpersonal Psychotherapy for Treating Late-life Depression
Geriatric Depression: Getting Better, Getting Well

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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • 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
  • Behavioral: Clinical Monitoring
    16 weeks of depression care management(DCM). No psychotherapy will be provided.
  • 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)
    Interventions:
    • Drug: Escitalopram
    • Behavioral: Interpersonal Psychotherapy
  • 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)
    Interventions:
    • Drug: Escitalopram
    • Behavioral: Clinical Monitoring

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
319
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00177294
R01 MH037869-01, R01MH037869, 0404007, DATR A4-GPS
Yes
University of Pittsburgh
University of Pittsburgh
National Institute of Mental Health (NIMH)
Principal Investigator: Charles F. Reynolds III, MD University of Pittsburgh Professor of Psychiatry, Neurology, and Neuroscience
University of Pittsburgh
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP