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

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01942187

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Dysthymic Disorder Depressive Disorder Not Otherwise Specified (NOS)	Drug: Aripiprazole Drug: Bupropion Behavioral: Problem Solving Therapy	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Comparison of Medication Augmentation and Problem Solving Therapy

Anticipated Study Start Date :

Aug 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Medication Augmentation 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.	Drug: Aripiprazole Medication augmentation with Abilify (aripiprazole), in participants who have not responded to Selective Serotonin Reuptake Inhibitor (SSRI) treatment. Other Names: Abilify Drug: Bupropion Medication augmentation with Wellbutrin (bupropion), in participants who have not responded to SSRI treatment. Other Names: Wellbutrin
Active Comparator: Problem Solving Therapy Treatment for 12 weeks with weekly sessions of Problem Solving Therapy, with a trained therapist.	Behavioral: Problem Solving Therapy Weekly specialized psychotherapy

Arm

Intervention/Treatment

Active Comparator: Medication Augmentation

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.

Drug: Aripiprazole

Medication augmentation with Abilify (aripiprazole), in participants who have not responded to Selective Serotonin Reuptake Inhibitor (SSRI) treatment.

Other Names:

Abilify

Drug: Bupropion

Medication augmentation with Wellbutrin (bupropion), in participants who have not responded to SSRI treatment.

Other Names:

Wellbutrin

Active Comparator: Problem Solving Therapy

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

Behavioral: Problem Solving Therapy

Weekly specialized psychotherapy

Outcome Measures

Primary Outcome Measures

Hamilton Psychiatric Rating Scale for Depression [12 weeks]
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 [1 Day]
IQ test designed to assess specific and overall cognitive capabilities and is individually administered

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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