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Augmenting Antidepressant Treatment With Interpersonal Psychotherapy for Treating Late-Life Depression
This study is ongoing, but not recruiting participants.
Study NCT00177294   Information provided by National Institute of Mental Health (NIMH)
First Received: September 12, 2005   Last Updated: February 19, 2009   History of Changes

September 12, 2005
February 19, 2009
April 2004
August 2009   (final data collection date for primary outcome measure)
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 [ Time Frame: Measured at Week 6 or 22 ] [ Designated as safety issue: No ]
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
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). [ Time Frame: Measured at Week 6 or 22 ] [ Designated as safety issue: No ]
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).
 
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

Phase IV
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study
Depression
  • Drug: Escitalopram
  • Behavioral: Interpersonal Psychotherapy
  • Drug: Clinical Monitoring
  • Experimental: Participants who are partial responders to escitalopram in first 6 weeks of treatment and receive 16 weeks of extension therapy with escitalopram 20 mg, plus interpersonal psychotherapy (IPT)
  • Active Comparator: Participants who receive 16 weeks of extension therapy with escitalopram 20 mg plus medication clinical monitoring with no psychotherapy
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
320
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of unipolar major 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
  • 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
Charles F. Reynolds III, MD, University of Pittsburgh
R01 MH037869-01, 0404007, DATR A4-GPS
National Institute of Mental Health (NIMH)
 
Principal Investigator: Charles F. Reynolds III, MD University of Pittsburgh Professor of Psychiatry, Neurology, and Neuroscience
National Institute of Mental Health (NIMH)
February 2009

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