Clinical trial NCT00608543: Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression
Official title: Aripiprazole Augmentation of SSRI Antidepressant Therapy in Treatment Refractory Depression: Assessment of Symptom Reduction, Psychosocial Function, and Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: cognitive function
psychosocial function
augmentation
treatment refractory depression
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-02-06
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Our target population will have been adequately treated with one of three selective serotonin reuptake inhibitors (SSRIs; escitalopram, citalopram, or 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.


Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Primary diagnosis of Major Depressive Disorder (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)
* Hamilton Rating Scale for Depression, 17-item (HRSD17) score less than or equal to 14 and/or Clinical Global Impression - Severity (CGI-S) score less than or equal to 3
* Self-reported difficulties with cognition and/or concentration, and an Inventory for Depressive Symptomatology Clinician-Rated, 30-item (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 Not Otherwise Specified \[NOS\]), 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 Mini Mental Status Examination (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.

Primary outcomes:
measure: Stockings of Cambridge (SOC) Mean Initial Thinking Time for 3-move Problems
timeFrame: baseline and 6 weeks
measure: Stockings of Cambridge (SOC) Mean Initial Thinking Time for 5-move Problems
timeFrame: baseline and 6 weeks
measure: Spatial Working Memory (SWM) Between Errors for 6-move Problems
timeFrame: baseline and 6 weeks
measure: Spatial Working Memory (SWM) Strategy Score
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: Quality of Life Enjoyment and Satisfaction Questionnaire
timeFrame: 6 weeks
measure: Change in Hamilton Rating Scale for Depression (HRSD - 17-item)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
Study officials:
References: