Overview

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

Status:
Withdrawn
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York State Psychiatric Institute
Treatments:
Aripiprazole
Bupropion
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