Clinical trial NCT01942187: A Comparison of Medication Augmentation and PST in the Treatment of Depression in Older Adults
Official title: A Comparison of Medication Augmentation and Problem Solving Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Major Depressive Disorder
Dysthymic Disorder
Depressive Disorder Not Otherwise Specified (NOS)
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hamilton Psychiatric Rating Scale for Depression
timeFrame: 12 weeks
Secondary outcomes:
measure: Wechsler Abbreviated Scale of Intelligence (WASI) Matrix Reasoning Test
timeFrame: 1 Day
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Bret Rutherford, MD
role: PRINCIPAL_INVESTIGATOR
References: