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
  Purpose

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.


Condition Intervention Phase
Depressive Disorder, Major
Drug: Abilify (aripiprazole)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Abilify (Aripiprazole) as an Adjunctive Treatment for Refractory Unipolar Depression.

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HDRS)

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

Estimated Enrollment: 15
Study Start Date: March 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220636

Locations
United States, New York
Mood Disorders Research Program, St. Luke's Roosevelt Hospital
New York, New York, United States, 10019
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Bristol-Myers Squibb
Investigators
Principal Investigator: David J. Hellerstein, MD NY State Psychiatric Institute, and St. Luke's - Roosevelt Hospital Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00220636     History of Changes
Other Study ID Numbers: SLR-04-028
Study First Received: September 21, 2005
Last Updated: June 5, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Major Depression
Depression
Unipolar Depression
Treatment Resistant Depression
Adjunctive treatment

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 26, 2014