Aripiprazole Augmentation Versus Switching to Different Class of Antidepressants in Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Aripiprazole
switching to different class of antidepressant
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, depressive, major, aripiprazole, switching, augmentation, antidepressant
Eligibility Criteria
Inclusion Criteria:
- Patients who are older than 20 years of age have a diagnosis of MDD without psychotic features, as defined by DSM-IV-TR.
- Patients have to report an inadequate response to a current antidepressant treatment. Inadequate response to antidepressant is defined as: total score of HDRS-17 is more than 14), despite adequate dose of current antidepressant treatment for at least 6 weeks in the current episode(co-administered with ATRQ)
- Classification of antidepressants which can be included in the study(list for suggestion): Escitalopram 10~20mg/day, fluoxetine 20~40mg/day,paroxetine controlled release(CR) 25~62.5mg or paroxetine 20~40mg, sertraline 100~150mg,bupropion XL(SR) 150~300mg, mirtazapine 15~45mg,venlafaxine immediate or extended release(IR or ER) 112.5~225mg/day, duloxetine 60mg [same criteria for generic medications as brand drugs]
Exclusion Criteria:
- Those who are first episode, drug naive MDD subjects
- Those who have a current Axis I diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar 1 or 2 disorder, eating disorder, obsessive-compulsive disorder, panic disorder, or posttraumatic stress disorder
- Those who have a clinically significant current Axis 2 diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder
- Those who experience hallucinations, delusion, or any psychotic symptomatology in the current depressive episode
- Those who have met DSM-IV-TR criteria for any significant substance use disorder within the past 12 months (except nicotine)
- Those who have known allergy,hypersensitivity or previous unresponsiveness to aripiprazole or known intolerance to other study medications
- Those who have had cognitive-behavioral therapy or other psychotherapy, or they have the potential need to be treated with them during the study periods
- Those who are complicated with serious medical problem, such as severe renal, hepatic dysfunction, cardiovascular, lung, gastrointestinal, endocrine, nervous, infectious disease, or neoblastic, metabolic disease
- Those who have shown previous unresponsiveness to adequate antidepressant trials more than 2 episodes or with 3 or more antidepressant treatments
- Those who have chronic liver or renal disease
- Those who are pregnant or brest-feeding
- Those who have participated in a clinical trial with aripiprazole or any other investigational product within the past month(include randomized, double-blind, placebo-controlled or open-label study; but chart review,observational study can be enrolled)
- Those who had a history of thyroid pathology, neuroleptic malignant syndrome, or serotonin syndrome
- Those who have received adjunctive antipsychotic plus antidepressant for more than 3 weeks during the current episode
- Those who have received electroconvulsive therapy for the current episode
- Those who have shown an inadequate response to previous ECT in any episode
- Those who have a suicidal risk
- Those who are likely to require prohibited concomitant therapy during the trial
- Those who have received treatment with a monoamine oxidase inhibitor within 2 weeks prior to enrollment
Sites / Locations
- Korean Univ Ansan Hospital; Bucheon St.Mary Hospital; DonggukUniv Gyeongju Hospital; Catholic University of Korea St. Paul's Hospital
- Chang Gung Memorial Hospital; Kaohsiung Medical University Chung-ho Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
aripiprazole augmentation
different class of antidepressant
Arm Description
Outcomes
Primary Outcome Measures
Change of total score of MADRS
MADRS: montgomery Asberg Depression Rating Scale
Response rate
response rate is defined as a reduction in MADRS total score of at least 50% relative to the beginning of the randomized phase (baseline)
Secondary Outcome Measures
Response rate
Remission rate
remission rate is defined as an absolute MADRS total score of ≤10 at the end of treatment
Change of total score of HDRS-17
HDRS-17: Hamilton Depression Rating Scale-17 item
Change of total score of CGI-S
CGI-S: Clinical Global Impression-Severity Score
Change of total score of IFS
IFS: Iowa Fatigue Scale
Change of total score of SDS
SDS: Sheehan Disability Scale
Patients' ratio who have have scored 1 or 2 in the score of CGI-Improvement
CGI-I: Clinical Global Impression-Improvement Score
Full Information
NCT ID
NCT01488266
First Posted
December 4, 2011
Last Updated
December 6, 2011
Sponsor
Korea University
Collaborators
Korea OIAA, Taiwan Otsuka Pharm. Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01488266
Brief Title
Aripiprazole Augmentation Versus Switching to Different Class of Antidepressants in Major Depressive Disorder
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 Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University
Collaborators
Korea OIAA, Taiwan Otsuka Pharm. Co., Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to compare the efficacy and safety of aripiprazole as adjunctive therapy versus switching to different class of antidepressants for treating major depressive disorder partially or minimally responsive to ongoing antidepressant treatment.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, depressive, major, aripiprazole, switching, augmentation, antidepressant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
aripiprazole augmentation
Arm Type
Experimental
Arm Title
different class of antidepressant
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
abilify
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
switching to different class of antidepressant
Other Intervention Name(s)
escitalopram, fluoxetine, paroxetine, sertraline, bupropion XL, mirtazapine, venlafaxine, milnacipran, duloxetine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of total score of MADRS
Description
MADRS: montgomery Asberg Depression Rating Scale
Time Frame
From baseline to end of treatment
Title
Response rate
Description
response rate is defined as a reduction in MADRS total score of at least 50% relative to the beginning of the randomized phase (baseline)
Time Frame
at 2 weeks
Secondary Outcome Measure Information:
Title
Response rate
Time Frame
at week 2,4 and 6
Title
Remission rate
Description
remission rate is defined as an absolute MADRS total score of ≤10 at the end of treatment
Time Frame
at week 2,4and 6
Title
Change of total score of HDRS-17
Description
HDRS-17: Hamilton Depression Rating Scale-17 item
Time Frame
from baseline to end of treatment
Title
Change of total score of CGI-S
Description
CGI-S: Clinical Global Impression-Severity Score
Time Frame
from baseline to end of treatment
Title
Change of total score of IFS
Description
IFS: Iowa Fatigue Scale
Time Frame
from baseline to end of treatment
Title
Change of total score of SDS
Description
SDS: Sheehan Disability Scale
Time Frame
from baseline to end of treatment
Title
Patients' ratio who have have scored 1 or 2 in the score of CGI-Improvement
Description
CGI-I: Clinical Global Impression-Improvement Score
Time Frame
at the end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are older than 20 years of age have a diagnosis of MDD without psychotic features, as defined by DSM-IV-TR.
Patients have to report an inadequate response to a current antidepressant treatment. Inadequate response to antidepressant is defined as: total score of HDRS-17 is more than 14), despite adequate dose of current antidepressant treatment for at least 6 weeks in the current episode(co-administered with ATRQ)
Classification of antidepressants which can be included in the study(list for suggestion): Escitalopram 10~20mg/day, fluoxetine 20~40mg/day,paroxetine controlled release(CR) 25~62.5mg or paroxetine 20~40mg, sertraline 100~150mg,bupropion XL(SR) 150~300mg, mirtazapine 15~45mg,venlafaxine immediate or extended release(IR or ER) 112.5~225mg/day, duloxetine 60mg [same criteria for generic medications as brand drugs]
Exclusion Criteria:
Those who are first episode, drug naive MDD subjects
Those who have a current Axis I diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar 1 or 2 disorder, eating disorder, obsessive-compulsive disorder, panic disorder, or posttraumatic stress disorder
Those who have a clinically significant current Axis 2 diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder
Those who experience hallucinations, delusion, or any psychotic symptomatology in the current depressive episode
Those who have met DSM-IV-TR criteria for any significant substance use disorder within the past 12 months (except nicotine)
Those who have known allergy,hypersensitivity or previous unresponsiveness to aripiprazole or known intolerance to other study medications
Those who have had cognitive-behavioral therapy or other psychotherapy, or they have the potential need to be treated with them during the study periods
Those who are complicated with serious medical problem, such as severe renal, hepatic dysfunction, cardiovascular, lung, gastrointestinal, endocrine, nervous, infectious disease, or neoblastic, metabolic disease
Those who have shown previous unresponsiveness to adequate antidepressant trials more than 2 episodes or with 3 or more antidepressant treatments
Those who have chronic liver or renal disease
Those who are pregnant or brest-feeding
Those who have participated in a clinical trial with aripiprazole or any other investigational product within the past month(include randomized, double-blind, placebo-controlled or open-label study; but chart review,observational study can be enrolled)
Those who had a history of thyroid pathology, neuroleptic malignant syndrome, or serotonin syndrome
Those who have received adjunctive antipsychotic plus antidepressant for more than 3 weeks during the current episode
Those who have received electroconvulsive therapy for the current episode
Those who have shown an inadequate response to previous ECT in any episode
Those who have a suicidal risk
Those who are likely to require prohibited concomitant therapy during the trial
Those who have received treatment with a monoamine oxidase inhibitor within 2 weeks prior to enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changsu Han, MD,PhD, MHS
Organizational Affiliation
Korea Univ Ansan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Korean Univ Ansan Hospital; Bucheon St.Mary Hospital; DonggukUniv Gyeongju Hospital; Catholic University of Korea St. Paul's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Chang Gung Memorial Hospital; Kaohsiung Medical University Chung-ho Memorial Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Aripiprazole Augmentation Versus Switching to Different Class of Antidepressants in Major Depressive Disorder
We'll reach out to this number within 24 hrs