Abilify as an Adjunctive Treatment for Refractory Depression
This study has been completed.
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
First received: September 21, 2005
Last updated: February 18, 2015
Last verified: October 2014
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.
Depressive Disorder, Major
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Abilify (Aripiprazole) as an Adjunctive Treatment for Refractory Unipolar Depression
Primary Outcome Measures:
- Hamilton Depression Rating Scale (HDRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Clinician rated measure of depression, mean score; this study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7) Outcome is the number of these subjects whose depression "responded" after treatment with aripiprazole, which means a 50% or greater decrease in Hamilton Depression Rating Scale scores at week 12.
Secondary Outcome Measures:
- Clinical Global Impressions Improvement Scale (CGI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
clinician rated improvement, score on CGI scale ranging from 1 (very much improved) to 7 (very much worse)
- Change in Global Assessment of Functioning Scale (GAFS) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
Ranging from 0 to 100, with higher score indicating better global functioning. Outcome is the post-treatment GAFS score compared to the pre-treatment GAFS score.
- Change in Beck Depression Inventory (BDI) Score [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.
Outcome is the subject's total BDI score post-treatment compared to the subject's total BDI score pre-treatment.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2007 (Final data collection date for primary outcome measure)
Aripiprazole 5 to 30 mg/day
Aripiprazole dose ranging from 5 to 30 mg/day, augmenting antidepressant treatment. Aripiprazole is used as an augmenting medication on an open label basis for patients on antidepressant medication who continue to have depressive symptoms. This is an open label case series in which all subjects receive aripiprazole augmentation. There is no comparator group.
Other Name: Abilify
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.
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00220636
|Depression Evaluation Service, NY State Psychiatric Institute
|New York, New York, United States, 10032 |
St. Luke's-Roosevelt Hospital Center
||David J. Hellerstein, MD
||NY State Psychiatric Institute, and St. Luke's - Roosevelt Hospital Center
||St. Luke's-Roosevelt Hospital Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 21, 2005
|Results First Received:
||April 15, 2009
||February 18, 2015
||United States: Institutional Review Board
Keywords provided by St. Luke's-Roosevelt Hospital Center:
Treatment Resistant Depression
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 27, 2015
Depressive Disorder, Major
Central Nervous System Agents
Central Nervous System Depressants
Physiological Effects of Drugs