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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by New York State Psychiatric Institute
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01942187
First received: September 10, 2013
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Dysthymic Disorder
Depressive Disorder Not Otherwise Specified (NOS)
Drug: Aripiprazole
Drug: Bupropion
Behavioral: Problem Solving Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Medication Augmentation and Problem Solving Therapy

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Hamilton Psychiatric Rating Scale for Depression [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Beck Depression Inventory [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Wechsler Test of Adult Reading (WTAR) [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • 30-item Folstein Mini Mental Status Exam [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Boston Naming Test [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Controlled Oral Word Association Test (COWAT) [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Animal Naming Test [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Trails Making Test - Parts A and B (Trails A and B) [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • The Digit Symbol subtest (WAIS-III) [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Stroop Color - Word Test (Stroop) [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Digit Span [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Letter Number Sequencing [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Mattis Dementia Rating Scale -Initiation and Perseveration subtest (DRS-I/P) [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Verbal Learning Test (Rey AVLT) [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Wechsler Abbreviated Scale of Intelligence (WASI) Matrix Reasoning Test [ Time Frame: 1 Day ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Abilify
Drug: Bupropion
Medication augmentation with Wellbutrin (bupropion), in participants who have not responded to SSRI treatment.
Other Name: 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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01942187

Contacts
Contact: Emily Pott, BS 646-774-8652 pottemi@nyspi.columbia.edu

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Emily Pot, BS    646-774-8652    pottemi@nyspi.columbia.edu   
Principal Investigator: Bret Rutherford, MD         
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Bret Rutherford, MD New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01942187     History of Changes
Other Study ID Numbers: #6627
Study First Received: September 10, 2013
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dysthymic Disorder
Depressive Disorder, Major
Depressive Disorder
Depression
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes
Aripiprazole
Bupropion
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014