Abilify as an Adjunctive Treatment for Refractory Depression

NCT00220636 | Completed Phase 4 Results

• 1 other identifier: SLR-04-028
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder, Major

Keywords

Major Depression; Depression; Unipolar Depression; Treatment Resistant Depression; Adjunctive treatment

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HDRS)

  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.

  12 weeks

Secondary Outcomes (3)

• Clinical Global Impressions Improvement Scale (CGI)

  12 weeks

• Change in Global Assessment of Functioning Scale (GAFS)

  baseline and 12 weeks

• Change in Beck Depression Inventory (BDI) Score

  baseline and 12 weeks

Study Arms (1)

Aripiprazole

EXPERIMENTAL

Aripiprazole 5 to 30 mg/day

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

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.

Also known as: Abilify

Aripiprazole

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Depression Evaluation Service, NY State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

• Hellerstein DJ. Aripiprazole as an adjunctive treatment for refractory major depression. Prog Neuropsychopharmacol Biol Psychiatry. 2004 Dec;28(8):1347-8. doi: 10.1016/j.pnpbp.2004.06.016. No abstract available.

  PMID: 15588762 BACKGROUND

Related Links

• Web Site for the Mood Disorders Research Program, with information about the study and the process of getting involved in research in general and specifically at our site

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Open label study without comparison group.

Results Point of Contact

• Title: David Hellerstein MD
• Organization: NY State Psychiatric Institute

hellers@nyspi.columbia.edu

6467748000

Study Officials

• David J. Hellerstein, MD

  NY State Psychiatric Institute, and St. Luke's - Roosevelt Hospital Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 22, 2005
• Study Start: March 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: January 1, 2008
• Last Updated: May 26, 2016
• Results First Posted: February 20, 2015

Record last verified: 2014-10

Locations

US (1)