Abilify as an Adjunctive Treatment for Refractory Depression

• ClinicalTrials.gov Identifier: NCT00220636
• Recruitment Status: Completed
• First Posted: September 22, 2005
• Results First Posted: February 20, 2015
• Last Update Posted: May 26, 2016
• Sponsor: St. Luke's-Roosevelt Hospital Center
• Collaborator: Bristol-Myers Squibb
• Information provided by (Responsible Party): St. Luke's-Roosevelt Hospital Center

Tracking Information

• First Submitted Date: September 21, 2005
• First Posted Date: September 22, 2005
• Results First Submitted Date: April 15, 2009
• Results First Posted Date: February 20, 2015
• Last Update Posted Date: May 26, 2016
• Study Start Date: March 2005
• Actual Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 18, 2015)

Hamilton Depression Rating Scale (HDRS) [ Time Frame: 12 weeks ]

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.

• Original Primary Outcome Measures (submitted: September 21, 2005): Hamilton Depression Rating Scale (HDRS)
• Change History: Complete list of historical versions of study NCT00220636 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: February 18, 2015)

• Clinical Global Impressions Improvement Scale (CGI) [ Time Frame: 12 weeks ]
  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 ]
  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 ]
  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.

Original Secondary Outcome Measures (submitted: September 21, 2005)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Abilify as an Adjunctive Treatment for Refractory Depression
• Official Title: Abilify (Aripiprazole) as an Adjunctive Treatment for Refractory Unipolar Depression
• 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 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.
• 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 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Depressive Disorder, Major

Intervention

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 Name: Abilify

Study Arms

Experimental: Aripiprazole

Aripiprazole 5 to 30 mg/day

Intervention: Drug: Aripiprazole

• Publications *: Hellerstein DJ. Aripiprazole as an adjunctive treatment for refractory major depression. Prog Neuropsychopharmacol Biol Psychiatry. 2004 Dec;28(8):1347-8.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 21, 2005): 15
• Original Enrollment: Same as current
• Actual Study Completion Date: January 2008
• Actual Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00220636
• Other Study ID Numbers: SLR-04-028
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: St. Luke's-Roosevelt Hospital Center
• Study Sponsor: St. Luke's-Roosevelt Hospital Center
• Collaborators: Bristol-Myers Squibb

Investigators

• Principal Investigator: David J. Hellerstein, MD; NY State Psychiatric Institute, and St. Luke's - Roosevelt Hospital Center

• PRS Account: St. Luke's-Roosevelt Hospital Center
• Verification Date: October 2014