Aripiprazole Augmentation Versus Switching to Different Class of Antidepressants in Major Depressive Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01488266|
Recruitment Status : Unknown
Verified December 2011 by Chansu Han, MD, PhD, MHS, Korea University.
Recruitment status was: Active, not recruiting
First Posted : December 8, 2011
Last Update Posted : December 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Aripiprazole Drug: switching to different class of antidepressant||Not Applicable|
Most guidelines have suggested that those nonresponders or partial responders should be considered for a switch, combination or augmentation of treatment. Traditional augmentation agents, lithium, triiodothyronine (T3), buspirone, dopamine agonists, and stimulants have been commonly used for this patient population with limited supporting data. Recently, augmentation of atypical antipsychotics with antidepressant therapy has become a more commonly accepted treatment practice. This strategy has proven to be useful for enhancement of antidepressant effect, showing increased remission rates and early treatment effects on core depressive symptoms, and comorbid symptoms as well as antidepressant- mediated side effects (e.g., sexual dysfunction). Although, we have some limited treatment options to treat such patients as described above, it is not clear which treatment option would be best or acceptable for those patients in clinical practice yet.
Among above augmentation agents, aripiprazole is the first drug approved by U.S. FDA. as an augmentation therapy to antidepressants in the treatment of patients with MDD showing imminent efficacy and reliable safety profile through adequately-powered well-designed controlled clinical trials.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of Aripiprazole Augmentation vs Switching to Different Class of Antidepressants for Patients With MDD Who Are Partially/Minimally Responsive to Current Antidepressants:Randomized, Rater-blinded, Prospective Study|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||January 2013|
|Estimated Study Completion Date :||March 2013|
|Experimental: aripiprazole augmentation||
patients who are randomly assigned to adjunctive aripiprazole are treated with a starting dose of 2.5 (or 5) mg/day of aripiprazole, which can be increased weekly in 2.5~5mg/day increments to a maximum dose of 15 mg/day based on assessment of tolerability and clinical response. Doses can be decreased at any visit, based on tolerability; They continue to receive the same fixed-dose of the previously used antidepressant throughout the study period when patient is assigned to aripiprazole augmentation group.
Other Name: abilify
|Active Comparator: different class of antidepressant||
Drug: switching to different class of antidepressant
Patients randomly assigned to switching to different antidepressant have to discontinue the previously used antidepressant and receive different antidepressant within flexible therapeutic doses as indication label information (as based on clinicians' preference and experience). Dose increase is permitted until the first 2 weeks of the study.
- Change of total score of MADRS [ Time Frame: From baseline to end of treatment ]MADRS: montgomery Asberg Depression Rating Scale
- Response rate [ Time Frame: at 2 weeks ]response rate is defined as a reduction in MADRS total score of at least 50% relative to the beginning of the randomized phase (baseline)
- Response rate [ Time Frame: at week 2,4 and 6 ]
- Remission rate [ Time Frame: at week 2,4and 6 ]remission rate is defined as an absolute MADRS total score of ≤10 at the end of treatment
- Change of total score of HDRS-17 [ Time Frame: from baseline to end of treatment ]HDRS-17: Hamilton Depression Rating Scale-17 item
- Change of total score of CGI-S [ Time Frame: from baseline to end of treatment ]CGI-S: Clinical Global Impression-Severity Score
- Change of total score of IFS [ Time Frame: from baseline to end of treatment ]IFS: Iowa Fatigue Scale
- Change of total score of SDS [ Time Frame: from baseline to end of treatment ]SDS: Sheehan Disability Scale
- Patients' ratio who have have scored 1 or 2 in the score of CGI-Improvement [ Time Frame: at the end of treatment ]CGI-I: Clinical Global Impression-Improvement Score
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): NCT01488266
|Korea, Republic of|
|Korean Univ Ansan Hospital; Bucheon St.Mary Hospital; DonggukUniv Gyeongju Hospital; Catholic University of Korea St. Paul's Hospital|
|Seoul, Korea, Republic of|
|Chang Gung Memorial Hospital; Kaohsiung Medical University Chung-ho Memorial Hospital|
|Study Chair:||Changsu Han, MD,PhD, MHS||Korea Univ Ansan Hospital|