Abilify Augmentation of SSRI Therapy in Treatment Refractory Depression

Condition(s) targeted: Major Depressive Disorder

Intervention: Aripiprazole (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Texas Southwestern Medical Center

Overall contact:
Tracy Greer, PhD, Phone: 214-648-0156, Email: tracy.greer@utsouthwestern.edu

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.

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

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study

Primary outcome: CANTAB neuropsychological tests

Secondary outcome:

Quality of Life Enjoyment and Satisfaction Questionnaire

Hamilton Rating Scale for Depression

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Tracy Greer, PhD, Phone: 214-648-0156, Email: tracy.greer@utsouthwestern.edu

University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 752390-9119, United States; Recruiting
Madhukar Trivedi, MD, Principal Investigator

Starting date: October 2005
Last updated: February 5, 2008