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

Major Depressive Disorder Clinical Trial

Official title:

A Comparison of Medication Augmentation and Problem Solving Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01942187
• Other study ID #: #6627
• Status: Withdrawn
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2019
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder Not Otherwise Specified (NOS)
• Depressive Disorder, Major
• Disease
• Dysthymic Disorder
• Major Depressive Disorder

Intervention

Drug:
• Aripiprazole
Medication augmentation with Abilify (aripiprazole), in participants who have not responded to Selective Serotonin Reuptake Inhibitor (SSRI) treatment.
• Bupropion
Medication augmentation with Wellbutrin (bupropion), in participants who have not responded to SSRI treatment.

Behavioral:
• Problem Solving Therapy
Weekly specialized psychotherapy

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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