Abilify Augmentation of SSRI Therapy in Treatment Refractory Depression

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by University of Texas Southwestern Medical Center. Recruitment status was Active, not recruiting

First Received on January 23, 2008. Last Updated on January 12, 2010 History of Changes

Sponsor:	University of Texas Southwestern Medical Center
Collaborator:	Bristol-Myers Squibb
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00608543

Purpose

Our target population will have been adequately treated with one of three SSRIs (escitalopram, citalopram, and sertraline) for at least 8-12 weeks and continue to experience symptoms of depression that have prompted them to seek additional treatment. Escitalopram, citalopram, and sertraline were selected for use in this study because they are among the most commonly selected SSRIs and they are associated with a reduced likelihood of drug-drug interactions with aripiprazole. After completion of the screening process, eligible participants will be augmented with aripiprazole (5, 10, or 15 mg) for 6 weeks. Participants will continue SSRI treatment with their prescribing physician, in conjunction with study participation. Symptom severity will be assessed on a weekly basis, and cognitive and psychosocial function will be assessed at pre- and post-augmentation. We hypothesize that aripiprazole augmentation will be associated with reductions in symptom severity, and with improved performance on measures of psychosocial and cognitive function.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Aripiprazole	Phase IV

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:	Aripiprazole Augmentation of SSRI Antidepressant Therapy in Treatment Refractory Depression: Assessment of Symptom Reduction, Psychosocial Function, and Cognitive Function

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Aripiprazole

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:

CANTAB neuropsychological tests [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of Life Enjoyment and Satisfaction Questionnaire [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Hamilton Rating Scale for Depression [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	October 2005
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Intervention Details:

varied dose (5, 10, 15 mg qd) for 6 wks

Other Name: Abilify

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-65
Primary diagnosis of MDD
Completion of at least 8-12 weeks (and no longer than 6 months) of treatment with escitalopram, citalopram, or sertraline, with at least 6 weeks at an adequate dose (i.e., 20 mg escitalopram; 40 mg citalopram; 150 mg sertraline)
HRSD17 score less than or equal to 14 and/or CGI-S score less than or equal to 3
Self-reported difficulties with cognition and/or concentration, and an IDS-C30 item #16 (Concentration and Decision Making) score less than or equal to 2
Ability to read and write in English (required because instructions for cognitive testing and several questionnaires are available only in English)

Exclusion Criteria:

Presence of untreated or unstable comorbid medical condition based on physician information or evidence at examination, such as hypertension, diabetes, hypothyroidism.
Presence of known cardiovascular disease or seizure disorder.
Presence of other primary psychiatric disorders or conditions (including depression due to medical conditions, currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (I, II, or NOS), schizophrenia, schizoaffective disorder, anorexia, bulimia, obsessive compulsive disorder, alcohol or substance abuse or dependence within the last 6 months)
Presence of organic brain injury or dementia, based on a cutoff score of < 20 on the MMSE.
Concomitant pharmacological or psychotherapeutic treatment (in addition to one SSRI as described in Inclusion Criteria) including but not limited to anxiolytics, neuroleptics, mood stabilizers
Hospitalization for mental illness within the past year.
For women, currently pregnant or planning to become pregnant in the next year.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608543

Locations

United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 752390-9119

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Bristol-Myers Squibb

More Information

No publications provided

Responsible Party:	Madhukar Trivedi, MD, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00608543 History of Changes
Other Study ID Numbers:	042004-011
Study First Received:	January 23, 2008
Last Updated:	January 12, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:

cognitive function
psychosocial function
augmentation
treatment refractory depression

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 February 09, 2012