Status:
COMPLETED
Abilify as an Adjunctive Treatment for Refractory Depression
Lead Sponsor:
St. Luke's-Roosevelt Hospital Center
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 depre...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00220636
Start Date
March 1 2005
End Date
January 1 2008
Last Update
May 26 2016
Active Locations (1)
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1
Depression Evaluation Service, NY State Psychiatric Institute
New York, New York, United States, 10032