Major Depressive DisorderNCT01488266
Aripiprazole Augmentation Versus Switching to Different Class of Antidepressants in Major Depressive Disorder
A study testing Aripiprazole and switching to different class of antidepressant in people with Major Depressive Disorder, run by Korea University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Aripiprazole and switching to different class of antidepressant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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]
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
South Korea1 site
Korean Univ Ansan Hospital; Bucheon St.Mary Hospital; DonggukUniv Gyeongju Hospital; Catholic University of Korea St. Paul's Hospital
Seoul
Taiwan1 site
Chang Gung Memorial Hospital; Kaohsiung Medical University Chung-ho Memorial Hospital
Taipei
About this study
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
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Aripiprazole, switching to different class of antidepressant
- Keywords
- depression, depressive, major, aripiprazole, switching, augmentation, antidepressant
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Also called abilify
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.
switching to different class of antidepressantDrug
Also called escitalopram, fluoxetine, paroxetine, sertraline
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.
| Study group | Role | What they receive |
|---|---|---|
| aripiprazole augmentation | Experimental | Not described Receives: Drug: Aripiprazole |
| different class of antidepressant | Active comparator | Not described Receives: Drug: switching to different class of antidepressant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of total score of MADRS
MADRS: montgomery Asberg Depression Rating Scale
Measured: From baseline to end of treatment
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)
Measured: at 2 weeks
Secondary outcomes (7)
Response rate
Measured: at week 2,4 and 6
Remission rate
remission rate is defined as an absolute MADRS total score of ≤10 at the end of treatment
Measured: at week 2,4and 6
Change of total score of HDRS-17
HDRS-17: Hamilton Depression Rating Scale-17 item
Measured: from baseline to end of treatment
Change of total score of CGI-S
CGI-S: Clinical Global Impression-Severity Score
Measured: from baseline to end of treatment
Change of total score of IFS
IFS: Iowa Fatigue Scale
Measured: from baseline to end of treatment
Change of total score of SDS
SDS: Sheehan Disability Scale
Measured: from baseline to end of treatment
Patients' ratio who have have scored 1 or 2 in the score of CGI-Improvement
CGI-I: Clinical Global Impression-Improvement Score
Measured: at the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Collaborators
- Korea OIAA, Taiwan Otsuka Pharm. Co., Ltd
- Responsible party
- Principal investigator, Chansu Han, MD, PhD, MHS, Korea University
- Investigators
- Changsu Han, MD,PhD, MHS, Study chair, Korea Univ Ansan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488266
- Sponsor's protocol ID
- CASCADE
- Status last verified
- Dec 2011
- First submitted
- 4 Dec 2011
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01488266
- Acronym / sponsor ID
- CASCADE
- Conditions
- Major Depressive Disorder
- Keywords
- depression, depressive, major, aripiprazole, switching, augmentation, antidepressant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Collaborators
- Korea OIAA, Taiwan Otsuka Pharm. Co., Ltd
- Study start
- Nov 2011
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aripiprazole augmentation | Experimental | Drug: Aripiprazole |
| different class of antidepressant | Active comparator | Drug: switching to different class of antidepressant |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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]
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AripiprazoleAlso: abilifypatients 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. | Drug | aripiprazole augmentation |
| switching to different class of antidepressantAlso: escitalopram, fluoxetine, paroxetine, sertralinePatients 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. | Drug | different class of antidepressant |
Primary outcome
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)
7 secondary outcomes
Response rate
Time frame: at week 2,4 and 6
Remission rate
Time frame: at week 2,4and 6
Change of total score of HDRS-17
Time frame: from baseline to end of treatment
Change of total score of CGI-S
Time frame: from baseline to end of treatment
Change of total score of IFS
Time frame: from baseline to end of treatment
Change of total score of SDS
Time frame: from baseline to end of treatment
Patients' ratio who have have scored 1 or 2 in the score of CGI-Improvement
Time frame: at the end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changsu Han, MD,PhD, MHS study chair
Korea Univ Ansan Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aripiprazole and switching to different class of antidepressant in people with Major Depressive Disorder, run by Korea University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of total score of MADRS (time frame: From baseline to end of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2011.