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

New York State Psychiatric Institute

Status and phase

Withdrawn

Phase 4

Conditions

Major Depressive Disorder

Dysthymic Disorder

Depressive Disorder Not Otherwise Specified (NOS)

Treatments

Drug: Aripiprazole

Behavioral: Problem Solving Therapy

Drug: Bupropion

Study type

Interventional

Funder types

Other

Identifiers

NCT01942187

#6627

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

50 to 90 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Medication Augmentation

Active Comparator group

Description:

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.

Treatment: