Major Depressive DisorderPhase 4NCT01696617
Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder
A Phase 4 study testing Aripiprazole 6-week group and Aripiprazole 8-week group in people with Major Depressive Disorder, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators hypothesized that combined pharmacotherapy using adjunctive aripiprazole of standard antidepressants would be associated with improved depression response in Major depressive disorder, especially in Quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Aripiprazole 6-week group and Aripiprazole 8-week group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Feb 2012to Feb 2019
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age : 18-65
- Patients with major depressive disorder according to DSM-IV criteria that have lasted >8 weeks
- MADRS total score of 18 or higher
- Patients who responded inadequately (a score of >18 on the MADRS) to first-line antidepressant treatment of 4 week duration
- Current use of standard antidepressant treatment in monotherapy or combination of 2 antidepressants : escitalopram (10 - 20mg/d), fluoxetine(20 - 40mg/d), paroxetine CR(25 - 50mg/d), sertraline(100 - 150mg/d), mirtazapine (15 - 45mg/d), duloxetine (30 - 60mg/d) or venlafaxine ER(150-225mg/d)
Who cannot join
- Past history of hypersensitivity to aripiprazole
- Primary diagnosis of MDD with psychotic feature, bipolar disorder, schizophrenia, schizoaffective disorder, other psychotic disorder or anxiety disorder, a history of alcohol/ drug abuse within the past 12 months, or a diagnosis of dementia
- Clinically significant current Axis II (DSM-IV-TR) diagnosis
- A significant risk of suicide corroborated by a score of ≥5 on item 10(suicidal thoughts) on the MADRS scale or by clinical judgment of the investigator
- Pregnancy or in breast-feeding
- Presence of a serious medical illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease or physical disorder judged to significantly affect central nervous system function
- Patients taking antipsychotics, mood stabilizer or any psychotropic medications besides antidepressants, except benzodiazepines or beta blockers or hypnotics
- Patients with past treatment failures of aripiprazole
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesized that combined pharmacotherapy using adjunctive aripiprazole of standard antidepressants would be associated with improved depression response in Major depressive disorder, especially in Quality of life.
The investigators compare the mean changes in the quality of life between before add-on and 8 weeks treatment of aripiprazole and between before add-on and 6 weeks treatment of aripiprazole.
Read the detailed description
Previous study about quality of life measurement in patients with depression have been reported that quality of life have to be measured irrespective with the severity of depression because quality of life has some other aspect to depression.The investigators have designed a 6-week single blinded study with flexible dose aripiprazole augmentation, ranging from 2.5mg to maximum 20 mg (15mg for patients on fluoxetine or paroxetine), in patients who responded inadequately (a score of >18 on the MADRS) to first-line antidepressant pharmacotherapy. The investigators compare the mean changes from in the quality of life at 8 weeks.
- Conditions
- Major Depressive Disorder
- Being tested
- Aripiprazole 6-week group, Aripiprazole 8-week group
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aripiprazole 6-week groupDrug
Also called Abilify®
Aripiprazole 8-week groupDrug
Also called Abilify®
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole 8-week group | Experimental | Adjunctive aripiprazole 8-week treatment Receives: Drug: Aripiprazole 6-week group |
| Aripiprazole 6-week group | Active comparator | Adjunctive aripiprazole 6-week treatment Receives: Drug: Aripiprazole 8-week group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Scale (QOLS)
change of Quality of Life Scale (QOLS)
Measured: Change from Baseline at 8 weeks
Secondary outcomes (1)
Montgomery-Åsberg Depression Rating Scale
change of Montgomery-Åsberg Depression Rating Scale
Measured: Change from Baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study start10 Feb 2012
- Primary completionDec 2016
- Study completionFeb 2019
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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Yong Min Ahn, Seoul National University Hospital
- Investigators
- Yong Min Ahn, MD. Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696617
- Sponsor's protocol ID
- 031-KOC-1108i
- Status last verified
- Apr 2019
- First submitted
- 31 Jul 2012
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01696617
- Acronym / sponsor ID
- 031-KOC-1108i
- Conditions
- Major Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- 10 Feb 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 1 Oct 2012 (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 investigators hypothesized that combined pharmacotherapy using adjunctive aripiprazole of standard antidepressants would be associated with improved depression response in Major depressive disorder, especially in Quality of life.
The investigators compare the mean changes in the quality of life between before add-on and 8 weeks treatment of aripiprazole and between before add-on and 6 weeks treatment of aripiprazole.
Detailed description
Previous study about quality of life measurement in patients with depression have been reported that quality of life have to be measured irrespective with the severity of depression because quality of life has some other aspect to depression.The investigators have designed a 6-week single blinded study with flexible dose aripiprazole augmentation, ranging from 2.5mg to maximum 20 mg (15mg for patients on fluoxetine or paroxetine), in patients who responded inadequately (a score of >18 on the MADRS) to first-line antidepressant pharmacotherapy. The investigators compare the mean changes from in the quality of life at 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole 8-week group | Experimental | Drug: Aripiprazole 6-week groupAdjunctive aripiprazole 8-week treatment |
| Aripiprazole 6-week group | Active comparator | Drug: Aripiprazole 8-week groupAdjunctive aripiprazole 6-week treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age : 18-65
- Patients with major depressive disorder according to DSM-IV criteria that have lasted >8 weeks
- MADRS total score of 18 or higher
- Patients who responded inadequately (a score of >18 on the MADRS) to first-line antidepressant treatment of 4 week duration
- Current use of standard antidepressant treatment in monotherapy or combination of 2 antidepressants : escitalopram (10 - 20mg/d), fluoxetine(20 - 40mg/d), paroxetine CR(25 - 50mg/d), sertraline(100 - 150mg/d), mirtazapine (15 - 45mg/d), duloxetine (30 - 60mg/d) or venlafaxine ER(150-225mg/d)
Key exclusion criteria (8 listed)
- Past history of hypersensitivity to aripiprazole
- Primary diagnosis of MDD with psychotic feature, bipolar disorder, schizophrenia, schizoaffective disorder, other psychotic disorder or anxiety disorder, a history of alcohol/ drug abuse within the past 12 months, or a diagnosis of dementia
- Clinically significant current Axis II (DSM-IV-TR) diagnosis
- A significant risk of suicide corroborated by a score of ≥5 on item 10(suicidal thoughts) on the MADRS scale or by clinical judgment of the investigator
- Pregnancy or in breast-feeding
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 |
|---|---|---|
| Aripiprazole 6-week groupAlso: Abilify® | Drug | Aripiprazole 8-week group |
| Aripiprazole 8-week groupAlso: Abilify® | Drug | Aripiprazole 6-week group |
Primary outcome
Quality of Life Scale (QOLS)
Time frame: Change from Baseline at 8 weeks
change of Quality of Life Scale (QOLS)
1 secondary outcome
Montgomery-Åsberg Depression Rating Scale
Time frame: Change from Baseline at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
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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.
Yong Min Ahn, MD. Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole 6-week group and Aripiprazole 8-week group in people with Major Depressive Disorder, run by Seoul National University Hospital at 1 site in South Korea.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of Life Scale (QOLS) (time frame: Change from Baseline at 8 weeks). 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 9 Apr 2019.