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Sponsors and Collaborators: |
St. Luke's-Roosevelt Hospital Center Bristol-Myers Squibb |
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Information provided by: | St. Luke's-Roosevelt Hospital Center |
ClinicalTrials.gov Identifier: | NCT00220636 |
This is a study of the effectiveness of adding Abilify (aripiprazole), an atypical antipsychotic medication, to ongoing 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.
Condition | Intervention | Phase |
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Depressive Disorder, Major |
Drug: Abilify (aripiprazole) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Abilify (Aripiprazole) as an Adjunctive Treatment for Refractory Unipolar Depression. |
Estimated Enrollment: | 15 |
Study Start Date: | March 2005 |
This is a pilot study of the effectiveness of adding Abilify (aripiprazole), an atypical antipsychotic medication, to ongoing 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: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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)
Exclusion Criteria:
United States, New York | |
Mood Disorders Research Program, St. Luke's Roosevelt Hospital | |
New York, New York, United States, 10019 |
Principal Investigator: | David J. Hellerstein, MD | NY State Psychiatric Institute, and St. Luke's - Roosevelt Hospital Center |
Study ID Numbers: | SLR-04-028 |
Study First Received: | September 21, 2005 |
Last Updated: | June 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00220636 History of Changes |
Health Authority: | United States: Institutional Review Board |
Major Depression Depression Unipolar Depression Treatment Resistant Depression Adjunctive treatment |
Tranquilizing Agents Depression Mental Disorders Psychotropic Drugs Mood Disorders Central Nervous System Depressants |
Aripiprazole Depressive Disorder, Major Antipsychotic Agents Depressive Disorder Behavioral Symptoms |
Depression Tranquilizing Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Depressive Disorder, Major Depressive Disorder Antipsychotic Agents |
Pharmacologic Actions Behavioral Symptoms Mental Disorders Therapeutic Uses Mood Disorders Aripiprazole Central Nervous System Agents |