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Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression

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ClinicalTrials.gov Identifier: NCT00608543
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : October 26, 2012
Last Update Posted : October 26, 2012
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Prabha Sunderajan, University of Texas Southwestern Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Aripiprazole Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2005
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

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Arms and Interventions
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Arm Intervention/treatment
Aripiprazole augmentation
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
varied dose (5, 10, 15 mg qd) for 6 wks
Other Name: Abilify


Outcome Measures
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Primary Outcome Measures :
  1. Stockings of Cambridge (SOC) Mean Initial Thinking Time for 3-move Problems [ Time Frame: baseline and 6 weeks ]
    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.

  2. Stockings of Cambridge (SOC) Mean Initial Thinking Time for 5-move Problems [ Time Frame: baseline and 6 weeks ]
    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.

  3. Spatial Working Memory (SWM) Between Errors for 6-move Problems [ Time Frame: baseline and 6 weeks ]
    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.

  4. Spatial Working Memory (SWM) Strategy Score [ Time Frame: baseline and 6 weeks ]
    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.


Secondary Outcome Measures :
  1. Quality of Life Enjoyment and Satisfaction Questionnaire [ Time Frame: 6 weeks ]
    The Q-LES-Q general activities is designed to measure subjective satisfaction and enjoyment, as opposed to function, in various domains including physical health, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. The raw score is converted into a percent of the maximum possible score and range from 0 to 100. Higher scores indicate greater enjoyment and satisfaction.

  2. Change in Hamilton Rating Scale for Depression (HRSD - 17-item) [ Time Frame: 6 weeks ]
    The HRSD 17-item scale is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression. Scores range from 0 to 52, with higher scores indicating higher levels of depression severity.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608543


Locations
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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
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Responsible Party: Prabha Sunderajan, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00608543     History of Changes
Other Study ID Numbers: 042004-011
First Posted: February 6, 2008    Key Record Dates
Results First Posted: October 26, 2012
Last Update Posted: October 26, 2012
Last Verified: March 2012

Keywords provided by Prabha Sunderajan, University of Texas Southwestern Medical Center:
cognitive function
psychosocial function
augmentation
treatment refractory depression

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Aripiprazole
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
 Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists