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

A Comparison of Medication Augmentation and Problem Solving Therapy

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.

Study Overview

• Status: Withdrawn
• Conditions: Major Depressive Disorder; Dysthymic Disorder; Depressive Disorder Not Otherwise Specified (NOS)
• Intervention / Treatment: Drug: Aripiprazole; Drug: Bupropion; Behavioral: Problem Solving Therapy

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York State Psychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Aripiprazole; Medication augmentation with Abilify (aripiprazole), in participants who have not responded to Selective Serotonin Reuptake Inhibitor (SSRI) treatment.; Other Names: Abilify; Drug: Bupropion; Medication augmentation with Wellbutrin (bupropion), in participants who have not responded to SSRI treatment.; Other Names: Wellbutrin
Active Comparator: Problem Solving Therapy; Treatment for 12 weeks with weekly sessions of Problem Solving Therapy, with a trained therapist.	Behavioral: Problem Solving Therapy; Weekly specialized psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wechsler Abbreviated Scale of Intelligence (WASI) Matrix Reasoning Test	IQ test designed to assess specific and overall cognitive capabilities and is individually administered	1 Day

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 10, 2013
• First Submitted That Met QC Criteria: September 12, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major; Dysthymic Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Aripiprazole; Bupropion
• Other Study ID Numbers: #6627