Depressive Disorder Not Otherwise Specified (NOS), Dysthymic Disorder, Major Depressive Disorder
Conditions
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.
Interventions
DRUGAripiprazole
Medication augmentation with Abilify (aripiprazole), in participants who have not responded to Selective Serotonin Reuptake Inhibitor (SSRI) treatment.
DRUGBupropion
Medication augmentation with Wellbutrin (bupropion), in participants who have not responded to SSRI treatment.
BEHAVIORALProblem Solving Therapy
Weekly specialized psychotherapy
Sponsors
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed