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Abilify as an Adjunctive Treatment for Refractory Depression

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00220636
First received: September 21, 2005
Last updated: February 18, 2015
Last verified: October 2014

September 21, 2005
February 18, 2015
March 2005
March 2007   (final data collection date for primary outcome measure)
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.
Hamilton Depression Rating Scale (HDRS)
Complete list of historical versions of study NCT00220636 on ClinicalTrials.gov Archive Site
  • 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.

  • Clinical Global Impressions Scale (CGI)
  • Global Assessment of Functioning Scale (GAFS)
  • Beck Depression Inventory (BDI)
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 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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Depressive Disorder, Major
Drug: Aripiprazole
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 Names:
  • Abilify
  • Aripiprazole
Experimental: Aripiprazole
Aripiprazole 5 to 30 mg/day
Intervention: Drug: Aripiprazole
Hellerstein DJ. Aripiprazole as an adjunctive treatment for refractory major depression. Prog Neuropsychopharmacol Biol Psychiatry. 2004 Dec;28(8):1347-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
January 2008
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 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
No
St. Luke's-Roosevelt Hospital Center
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
October 2014

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