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A Comparison of Medication Augmentation and PST in the Treatment of Depression in Older Adults

Primary Purpose

Major Depressive Disorder, Dysthymic Disorder, Depressive Disorder Not Otherwise Specified (NOS)

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Bupropion
Problem Solving Therapy
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages 50-90, inclusive
  • Current diagnosis of major depressive disorder or dysthymia
  • Treatment with either citalopram 30/mg or duloxetine 60 mg/day (6 weeks total, with at least three weeks of treatment at that dose)
  • Hamilton Rating Scale for Depression (HRSD) >= 14
  • Willing and able to complete NP testing
  • Willing and able to complete medical exam, EKG, blood tests, and urine screen
  • Willing and able to give consent

Exclusion Criteria:

  • Meets criteria for psychotic depression
  • MMSE score <24
  • Bipolar disorder, psychotic disorder, or OCD
  • History of alcohol or drug dependence (excluding nicotine) within past six months
  • Suicide attempt within past six months or HRSD item 2 score > 2
  • Diagnosis of probable Alzheimer's disease
  • Diagnosis of probable vascular dementia
  • Acute, severe, or unstable medical illness
  • Patients in psychotherapy
  • Diagnosis of Parkinson's Disease
  • Blood glucose >200 and/or total cholesterol >250

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Medication Augmentation

Problem Solving Therapy

Arm Description

Medication augmentation with aripiprazole (Abilify) starting at 5mg/day, and increasing weekly in 5mg increments to a maximum of 15mg (10mg/day is the target dose). Under conditions of nonresponse after 6 weeks, aripiprazole will be switched for bupropion (Wellbutrin), starting at 150mg, and possibly increasing to 300mg after 2 weeks.

Treatment for 12 weeks with weekly sessions of Problem Solving Therapy, with a trained therapist.

Outcomes

Primary Outcome Measures

Hamilton Psychiatric Rating Scale for Depression
The Hamilton Depression Rating Scale (HAM-D) is used as a way of determining a patient's level of depression before, during, and after treatment. The scoring is based on the first 17 list items. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.

Secondary Outcome Measures

Wechsler Abbreviated Scale of Intelligence (WASI) Matrix Reasoning Test
IQ test designed to assess specific and overall cognitive capabilities and is individually administered

Full Information

First Posted
September 10, 2013
Last Updated
April 16, 2019
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01942187
Brief Title
A Comparison of Medication Augmentation and PST in the Treatment of Depression in Older Adults
Official Title
A Comparison of Medication Augmentation and Problem Solving Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled.
Study Start Date
August 2013 (Anticipated)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the effectiveness of two different augmentation strategies of antidepressant treatment for depressed older adults who have not responded to an adequate trial of antidepressant medication. The first augmentation strategy is Problem Solving Therapy (PST), a 12-week psychotherapy treatment that has been shown to be effective in depressed older adults. The second augmentation strategy is medication augmentation, which will begin with six weeks of aripiprazole, an atypical antipsychotic medication that has also been shown to be effective in depressed older adults who have failed a trial of antidepressant medication.
Detailed Description
Depression is common in older adults, and antidepressant medication is only effective in about 60% of patients seeking treatment. The purpose of this study is to compare the effectiveness of two different augmentation strategies of antidepressant treatment for depressed older adults who have not responded to an adequate trial of antidepressant medication. The first augmentation strategy is Problem Solving Therapy (PST), a 12-week psychotherapy treatment that has been shown to be effective in depressed older adults. The second augmentation strategy is medication augmentation, which will begin with six weeks of aripiprazole, an atypical antipsychotic medication that has also been shown to be effective in depressed older adults who have failed a trial of antidepressant medication. If patients have not remitted at the end of the 6 week aripiprazole trial, the aripiprazole will be stopped and they will be started on bupropion for the remaining 6 weeks of the study. Both aripiprazole augmentation and bupropion augmentation in depressed older adults have been approved by the FDA. No study has compared the effectiveness of PST and medication augmentation strategies for depressed older adults who are non-responders to an adequate trial of antidepressant medication in the current episode of their depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Dysthymic Disorder, Depressive Disorder Not Otherwise Specified (NOS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medication Augmentation
Arm Type
Active Comparator
Arm Description
Medication augmentation with aripiprazole (Abilify) starting at 5mg/day, and increasing weekly in 5mg increments to a maximum of 15mg (10mg/day is the target dose). Under conditions of nonresponse after 6 weeks, aripiprazole will be switched for bupropion (Wellbutrin), starting at 150mg, and possibly increasing to 300mg after 2 weeks.
Arm Title
Problem Solving Therapy
Arm Type
Active Comparator
Arm Description
Treatment for 12 weeks with weekly sessions of Problem Solving Therapy, with a trained therapist.
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Medication augmentation with Abilify (aripiprazole), in participants who have not responded to Selective Serotonin Reuptake Inhibitor (SSRI) treatment.
Intervention Type
Drug
Intervention Name(s)
Bupropion
Other Intervention Name(s)
Wellbutrin
Intervention Description
Medication augmentation with Wellbutrin (bupropion), in participants who have not responded to SSRI treatment.
Intervention Type
Behavioral
Intervention Name(s)
Problem Solving Therapy
Intervention Description
Weekly specialized psychotherapy
Primary Outcome Measure Information:
Title
Hamilton Psychiatric Rating Scale for Depression
Description
The Hamilton Depression Rating Scale (HAM-D) is used as a way of determining a patient's level of depression before, during, and after treatment. The scoring is based on the first 17 list items. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Wechsler Abbreviated Scale of Intelligence (WASI) Matrix Reasoning Test
Description
IQ test designed to assess specific and overall cognitive capabilities and is individually administered
Time Frame
1 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 50-90, inclusive Current diagnosis of major depressive disorder or dysthymia Treatment with either citalopram 30/mg or duloxetine 60 mg/day (6 weeks total, with at least three weeks of treatment at that dose) Hamilton Rating Scale for Depression (HRSD) >= 14 Willing and able to complete NP testing Willing and able to complete medical exam, EKG, blood tests, and urine screen Willing and able to give consent Exclusion Criteria: Meets criteria for psychotic depression MMSE score <24 Bipolar disorder, psychotic disorder, or OCD History of alcohol or drug dependence (excluding nicotine) within past six months Suicide attempt within past six months or HRSD item 2 score > 2 Diagnosis of probable Alzheimer's disease Diagnosis of probable vascular dementia Acute, severe, or unstable medical illness Patients in psychotherapy Diagnosis of Parkinson's Disease Blood glucose >200 and/or total cholesterol >250
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bret Rutherford, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Comparison of Medication Augmentation and PST in the Treatment of Depression in Older Adults

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