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Abilify as an Adjunctive Treatment for Refractory Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Aripiprazole Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Abilify (Aripiprazole) as an Adjunctive Treatment for Refractory Unipolar Depression
Study Start Date : March 2005
Actual Primary Completion Date : March 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Aripiprazole
Aripiprazole 5 to 30 mg/day
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220636


Locations
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United States, New York
Depression Evaluation Service, NY State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Bristol-Myers Squibb
Investigators
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Principal Investigator: David J. Hellerstein, MD NY State Psychiatric Institute, and St. Luke's - Roosevelt Hospital Center
More Information
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Additional Information:

Publications:

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Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00220636    
Other Study ID Numbers: SLR-04-028
First Posted: September 22, 2005    Key Record Dates
Results First Posted: February 20, 2015
Last Update Posted: May 26, 2016
Last Verified: October 2014
Keywords provided by St. Luke's-Roosevelt Hospital Center:
Major Depression
Depression
Unipolar Depression
Treatment Resistant Depression
Adjunctive treatment
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Aripiprazole
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
 Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists