Abilify as an Adjunctive Treatment for Refractory Depression.

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00220636
First received: September 21, 2005
Last updated: June 5, 2007
Last verified: June 2007

September 21, 2005
June 5, 2007
March 2005
Not Provided
Hamilton Depression Rating Scale (HDRS)
Same as current
Complete list of historical versions of study NCT00220636 on ClinicalTrials.gov Archive Site
  • Clinical Global Impressions Scale (CGI)
  • Global Assessment of Functioning Scale (GAFS)
  • Beck Depression Inventory (BDI)
Same as current
Not Provided
Not Provided
 
Abilify as an Adjunctive Treatment for Refractory Depression.
Abilify (Aripiprazole) as an Adjunctive Treatment for Refractory Unipolar Depression.

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Depressive Disorder, Major
Drug: Abilify (aripiprazole)
Not Provided
Hellerstein DJ. Aripiprazole as an adjunctive treatment for refractory major depression. Prog Neuropsychopharmacol Biol Psychiatry. 2004 Dec;28(8):1347-8. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
Not Provided
Not Provided

Inclusion Criteria:

  • Male and female outpatients between the ages of 18 and 70.
  • Patients with a principal 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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00220636
SLR-04-028
Not Provided
Not Provided
St. Luke's-Roosevelt Hospital Center
Bristol-Myers Squibb
Principal Investigator: David J. Hellerstein, MD NY State Psychiatric Institute, and St. Luke's - Roosevelt Hospital Center
St. Luke's-Roosevelt Hospital Center
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP