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

NCT01942187 | Withdrawn Phase 4

• 1 other identifier: #6627
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Wechsler Abbreviated Scale of Intelligence (WASI) Matrix Reasoning Test

  1 Day

Study Arms (2)

Medication Augmentation

ACTIVE COMPARATOR

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

Problem Solving Therapy

ACTIVE COMPARATOR

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

Behavioral: Problem Solving Therapy

Interventions

Aripiprazole DRUG

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

Also known as: Abilify

Medication Augmentation

Bupropion DRUG

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

Also known as: Wellbutrin

Medication Augmentation

Problem Solving Therapy BEHAVIORAL

Weekly specialized psychotherapy

Problem Solving Therapy

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Dysthymic Disorder

Interventions

Aripiprazole; Bupropion

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Propiophenones; Ketones; Organic Chemicals

Study Officials

• Bret Rutherford, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 13, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (1)