Abilify as an Adjunctive Treatment for Refractory Depression
Information source: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depressive Disorder, Major
Intervention: Aripiprazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: St. Luke's-Roosevelt Hospital Center Official(s) and/or principal investigator(s): David J. Hellerstein, MD, Principal Investigator, Affiliation: NY State Psychiatric Institute, and St. Luke's - Roosevelt Hospital Center
Summary
This is a study of the effectiveness of adding Abilify (aripiprazole), an atypical
antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI)
antidepressant treatment for depressed outpatients who are not responding fully to SSRI
treatment alone. It is hypothesized that patients' functioning will improve after 12 weeks
of treatment with Aripiprazole and SSRI medication.
Clinical Details
Official title: Abilify (Aripiprazole) as an Adjunctive Treatment for Refractory Unipolar Depression
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Hamilton Depression Rating Scale (HDRS)
Secondary outcome: Clinical Global Impressions Improvement Scale (CGI)Change in Global Assessment of Functioning Scale (GAFS) Change in Beck Depression Inventory (BDI) Score
Detailed description:
This is a pilot study of the effectiveness of adding Abilify (aripiprazole), an atypical
antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI)
antidepressant treatment for depressed outpatients who are not responding fully to SSRI
treatment alone. Fifteen subjects will be given aripiprazole in a flexible dosing schedule
and followed for 12 weeks, while continuing their ongoing SSRI medication. Assessments of
depressive symptoms, overall functioning, social functioning, and side effects will be
completed. It is hypothesized that patients' functioning will improve after 12 weeks of
treatment with Aripiprazole and SSRI medication.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male and female outpatients between the ages of 18 and 70.
- Patients with a principal Diagnostic and Statistical Manual fourth edition (DSM-IV)
diagnosis of Major Depressive Disorder, unipolar, nonpsychotic type
- Patients with a total of 14 or higher on the 17-item Hamilton Depression Scale at
baseline
- Patients who have had treatment with an SSRI at an adequate dose (see Table for a
minimum of 6 weeks (i. e. 6 wks at the dose defined as adequate in Table 2)
- Patients who agree to use acceptable method of birth control throughout the study
Exclusion Criteria:
- Patients with any of the following DSM-IV diagnoses: Delirium, Dementia, Amnestic, or
other Cognitive Disorders. Bipolar Disorder or cyclothymia, Schizophrenia, Delusional
(Paranoid) Disorders and Psychotic Disorders not elsewhere classified, Severe
Borderline Personality Disorder, Anorexia Nervosa, or Bulimia.
- Patients who, within the past 6 months, met DSM-IV criteria for abuse of or
dependence on any drug, including alcohol.
- Patients who are pregnant or nursing women.
- Patients who would pose a serious risk for suicide during the course of the study, as
evidenced by one of the following: (a) report of having a specific plan for killing
themselves, (b) a score of 3 or higher on the Hamilton Depression Rating Scale item
#3 as rated by the treating clinician at Week 0, or (c) a suicide attempt within the
last 6 months which required medical attention, such as an emergency room visit or
which is considered by the treating physician to have been possibly life threatening
- Patients with unstable medical conditions such as untreated or uncontrolled
hyperthyroidism, hypothyroidism, hypertension (defined as blood pressure>150/90),
cardiovascular disease, diabetes, HIV (by report of patient).
- Patients with a history of seizures.
Locations and Contacts
Depression Evaluation Service, NY State Psychiatric Institute, New York, New York 10032, United States
Additional Information
Web Site for the Mood Disorders Research Program, with information about the study and the process of getting involved in research in general and specifically at our site
Related publications: Hellerstein DJ. Aripiprazole as an adjunctive treatment for refractory major depression. Prog Neuropsychopharmacol Biol Psychiatry. 2004 Dec;28(8):1347-8.
Starting date: March 2005
Last updated: February 18, 2015
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