Depression (Major Depressive Disorder) Abilify (aripiprazole) as an Adjunctive Treatment for Refractory Unipolar Depression

Contact name: Sarai Batchelder, PhD

Phone: (212)-523-7666

Fax: (212)-523-7635

Email: sbatchel@chpnet.org

Disorder: Major Depressive Disorder

Geographic location: New York City

Other keywords: Treatment-resistant depression, refractory depression, Major Depression

Participant compensation: reimbursement for travel expenses

Time commitment required: 45 minute visits, 9 visits over 12 weeks

Drug trial: Yes

Recruitment end date (approximate): March 17, 2006

Study criteria (i.e., age or gender requirements):
1. Male and female outpatients between the ages of 18 and 70
2. Patients with a principal DSM-IV diagnosis of Major Depressive Disorder, unipolar, nonpsychotic type
3. Patients will have had a minimum of 6 weeks of treatment with an SSRI at an adequate dose
4. Patients who agree to use acceptable method of birth control throughout the study

Exclusion criteria:
1. Patients with any of the following DSM-IV diagnoses:
a) Delirium, Dementia, Amnestic, or other Cognitive Disorders.
b) Bipolar Disorder or cyclothymia, Schizophrenia, Delusional (Paranoid) Disorders and Psychotic Disorders not elsewhere classified, Severe Borderline Personality Disorder, Anorexia Nervosa, or Bulimia.
2. Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol.
3. Patients who are pregnant or nursing women.
4. Patients who would pose a serious risk for suicide during the course of the study or a suicide attempt within the last 6 months which required medical attention
5. Patients with unstable medical conditions such as untreated or uncontrolled hyperthyroidism, hypothyroidism, hypertension (BP>150/90), cardiovascular disease, diabetes, or HIV (by report of patient).
6. Patients with a history of seizures.

Brief description of study:
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. This is an open-label study in which all patients receive active medication (i.e. there is no placebo).

Additional information: