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

NCT ID: NCT01942187

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-12-31

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.

Conditions

Major Depressive Disorder; Dysthymic Disorder; Depressive Disorder Not Otherwise Specified (NOS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medication Augmentation

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.

Group Type: ACTIVE_COMPARATOR

Aripiprazole

Intervention Type: DRUG

Medication augmentation with Abilify (aripiprazole), in participants who have not responded to Selective Serotonin Reuptake Inhibitor (SSRI) treatment.

Bupropion

Intervention Type: DRUG

Medication augmentation with Wellbutrin (bupropion), in participants who have not responded to SSRI treatment.

Problem Solving Therapy

Treatment for 12 weeks with weekly sessions of Problem Solving Therapy, with a trained therapist.

Group Type: ACTIVE_COMPARATOR

Problem Solving Therapy

Intervention Type: BEHAVIORAL

Weekly specialized psychotherapy

Interventions

Aripiprazole

Medication augmentation with Abilify (aripiprazole), in participants who have not responded to Selective Serotonin Reuptake Inhibitor (SSRI) treatment.

Intervention Type: DRUG

Bupropion

Medication augmentation with Wellbutrin (bupropion), in participants who have not responded to SSRI treatment.

Intervention Type: DRUG

Problem Solving Therapy

Weekly specialized psychotherapy

Intervention Type: BEHAVIORAL

Other Intervention Names

Abilify; Wellbutrin

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Bret Rutherford

Associate Professor of Clinical Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bret Rutherford, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Other Identifiers

#6627

Identifier Type: -

Identifier Source: org_study_id