A Phase 4 interventional study of Aripiprazole and Bupropion in Major Depressive Disorder, Dysthymic Disorder and Depressive Disorder Not Otherwise Specified (NOS), sponsored by New York State Psychiatric Institute. Withdrawn at 1 site in United States. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-04-18.
Sponsored by New York State Psychiatric Institute · Phase 4, Interventional, and 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.
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
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Exclusion Criteria:
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 · Drug: Bupropion
Treatment for 12 weeks with weekly sessions of Problem Solving Therapy, with a trained therapist.
Behavioral: Problem Solving Therapy
Medication augmentation with Abilify (aripiprazole), in participants who have not responded to Selective Serotonin Reuptake Inhibitor (SSRI) treatment.
Also known as: Abilify
Medication augmentation with Wellbutrin (bupropion), in participants who have not responded to SSRI treatment.
Also known as: Wellbutrin
Weekly specialized psychotherapy
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.
Time frame: 12 weeks
Wechsler Abbreviated Scale of Intelligence (WASI) Matrix Reasoning Test
IQ test designed to assess specific and overall cognitive capabilities and is individually administered
Time frame: 1 Day
This study is withdrawn, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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New York State Psychiatric Institute