Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression

NCT00608543 | Completed Phase 4 Results

• 1 other identifier: 042004-011
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

cognitive function; psychosocial function; augmentation; treatment refractory depression

Outcome Measures

Primary Outcomes (4)

• Stockings of Cambridge (SOC) Mean Initial Thinking Time for 3-move Problems

  The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 3-move problems is the time (in milliseconds)taken to plan a problem solution for trials requiring 3 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.

  baseline and 6 weeks

• Stockings of Cambridge (SOC) Mean Initial Thinking Time for 5-move Problems

  The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 5-move problems is the time (in milliseconds) taken to plan a problem solution for trials requiring 5 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.

  baseline and 6 weeks

• Spatial Working Memory (SWM) Between Errors for 6-move Problems

  The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. Between errors are times the subject revisits a box in which a token was previously found; errors are calculated for 4-, 6-, and 8-box trials. Higher numbers indicate poorer performance. Errors reported are the difference between baseline and 6 weeks post-treatment.

  baseline and 6 weeks

• Spatial Working Memory (SWM) Strategy Score

  The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. The Strategy score represents the number of times a participant begins a search with the same box for 6- and 8-box problems. Minimum score is 8 and maximum score is 56. Higher numbers indicate poorer performance. Score reported is the difference between baseline and 6 weeks post-treatment.

  baseline and 6 weeks

Secondary Outcomes (2)

• Quality of Life Enjoyment and Satisfaction Questionnaire

  6 weeks

• Change in Hamilton Rating Scale for Depression (HRSD - 17-item)

  6 weeks

Study Arms (1)

Aripiprazole augmentation

OTHER

This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

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

Also known as: Abilify

Aripiprazole augmentation

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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).
• Hospitalization for mental illness within the past year.
• For women, currently pregnant or planning to become pregnant in the next year.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 752390-9119, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Note that because this is an augmentation trial, reported AEs are due to combined treatment with escitalopram, citalopram, or sertraline AND aripiprazole.

Results Point of Contact

• Title: Dr.Prabha Sunderajan
• Organization: UT Southwestern Medical Center

prabha.sunderajan@utsouthwestern.edu

214-648-0156

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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 6, 2008
• Study Start: October 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: October 26, 2012
• Results First Posted: October 26, 2012

Record last verified: 2012-03

Locations

US (1)