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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Comparison of Medication Augmentation and Problem Solving Therapy

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

Intervention / Treatment
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* Drug: Aripiprazole
* Drug: Bupropion
* Behavioral: Problem Solving Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wechsler Abbreviated Scale of Intelligence (WASI) Matrix Reasoning Test | IQ test designed to assess specific and overall cognitive capabilities and is individually administered | 1 Day |