Major Depressive DisorderPhase 4NCT01429831
Aripiprazole for the Augmentation of Antidepressant Therapy
A Phase 4 study testing Aripiprazole in people with Major Depressive Disorder, run by Taiwan Otsuka Pharm. Co., Ltd at 1 site in Taiwan.
Trial summary
The study aims to evaluate effectiveness and tolerability of aripiprazole augmentation in outpatients with major depressive disorder who have had inadequate response to antidepressants in Taiwan clinical practice. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Aripiprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2011to May 2013
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients, either gender, 20-65 years of age
- Patients diagnosed with major depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), who fulfill both the following criteria:
- Having at least one and no more than three inadequate responses of antidepressants
- HAM-D17 score ≥ 14
- Willing and able to comply with the study procedure and sign a written informed consent
Who cannot join
- Females who are pregnant/lactating or planning to be pregnant
- Presence of personality disorder cluster B (dramatic, emotional or erratic disorders) or any psychotic symptomatology in the current depressive episode based on Investigators judgment
- History of organic mental disorder within 1 year prior to the screening visit
- Acute risk of suicide attempts within 3 months prior to the initiation of study treatment (HAM D-17 score item 3 ≥ 3)
- Electroconvulsive therapy (ECT) for current episode
- Past exposure to aripiprazole treatment or any investigational product (including drug and invasive medical device) within 4 weeks prior to the initiation of study treatment
- History of substance / alcohol abuse within 1 year prior to the screening visit
- Patient with any medical or psychotic feature, including the presence of significant abnormal laboratory values, which is considered not suitable for this study by Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aripiprazole for the Augmentation of Antidepressant Therapy: An Observational, Outpatients Study in Inadequate Responders Diagnosed With Major Depressive Disorder
The study aims to evaluate effectiveness and tolerability of aripiprazole augmentation in outpatients with major depressive disorder who have had inadequate response to antidepressants in Taiwan clinical practice.
- Conditions
- Major Depressive Disorder
- Being tested
- Aripiprazole
- 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.
AripiprazoleDrug
starting aripiprazole dose from 2-5mg/day, dose adjustment by every week, and maximum dose can up to 15mg/day. The duration is 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole | Experimental | Not described Receives: Drug: Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
17-Item Hamilton Depression Rating Scale (HAM-D17) score
Primary effectiveness endpoint:
- Change from baseline in HAM-D17 score at Week 6
Secondary effectiveness endpoints:
- Change from baseline in HAM-D17 score at Week 1, 2 and 4
- Response rate at Week 1, 2, 4 and 6
- Response rate: decrease in HAM-D17 total score of at least 50%
- Remission rate at Week 1, 2, 4 and 6 - Remission rate: HAMD-17 score ≤ 7
Measured: Week 1, 2, 4 and 6
Secondary outcomes (3)
Clinical Global Impression of Severity (CGI-S) score
- Change from baseline in CGI-S score at Week 1, 2, 4 and 6
- CGI-I score at Week 1, 2, 4 and 6
Measured: Week 1, 2, 4 and 6
Sheehan Disability Scale (SDS) total score
Change from baseline in SDS total score at Week 1, 2, 4 and 6
Measured: Week 1, 2, 4 and 6
World Health Organization Quality of Life (WHOQOL-BREF) score
Change from baseline in WHOQOL-BREF score at Week 6
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2013
- Study completionMay 2013
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Otsuka Pharm. Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Te-Jen Lai, MD, Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429831
- Sponsor's protocol ID
- 031-TWB-1101i
- Status last verified
- May 2014
- First submitted
- 1 Sep 2011
- Last updated
- 21 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aripiprazole for the Augmentation of Antidepressant Therapy: An Observational, Outpatients Study in Inadequate Responders Diagnosed With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01429831
- Acronym / sponsor ID
- 031-TWB-1101i
- Conditions
- Major Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Taiwan Otsuka Pharm. Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 7 Sep 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 study aims to evaluate effectiveness and tolerability of aripiprazole augmentation in outpatients with major depressive disorder who have had inadequate response to antidepressants in Taiwan clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole | Experimental | Drug: Aripiprazole |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatients, either gender, 20-65 years of age
- Patients diagnosed with major depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), who fulfill both the following criteria:
- Willing and able to comply with the study procedure and sign a written informed consent
Key exclusion criteria (8 listed)
- Females who are pregnant/lactating or planning to be pregnant
- Presence of personality disorder cluster B (dramatic, emotional or erratic disorders) or any psychotic symptomatology in the current depressive episode based on Investigators judgment
- History of organic mental disorder within 1 year prior to the screening visit
- Acute risk of suicide attempts within 3 months prior to the initiation of study treatment (HAM D-17 score item 3 ≥ 3)
- Electroconvulsive therapy (ECT) for current episode
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 |
|---|---|---|
| Aripiprazolestarting aripiprazole dose from 2-5mg/day, dose adjustment by every week, and maximum dose can up to 15mg/day. The duration is 6 weeks. | Drug | Aripiprazole |
Primary outcome
17-Item Hamilton Depression Rating Scale (HAM-D17) score
Time frame: Week 1, 2, 4 and 6
Primary effectiveness endpoint: - Change from baseline in HAM-D17 score at Week 6 Secondary effectiveness endpoints: 1. Change from baseline in HAM-D17 score at Week 1, 2 and 4 2. Response rate at Week 1, 2, 4 and 6 - Response rate: decrease in HAM-D17 total score of at least 50% 3. Remission rate at Week 1, 2, 4 and 6 - Remission rate: HAMD-17 score ≤ 7
3 secondary outcomes
Clinical Global Impression of Severity (CGI-S) score
Time frame: Week 1, 2, 4 and 6
Sheehan Disability Scale (SDS) total score
Time frame: Week 1, 2, 4 and 6
World Health Organization Quality of Life (WHOQOL-BREF) score
Time frame: Week 6
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 21 May 2014.
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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.
Te-Jen Lai, MD principal investigator
Chung Shan Medical University
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 in people with Major Depressive Disorder, run by Taiwan Otsuka Pharm. Co., Ltd at 1 site in Taiwan.
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 21 May 2014. 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 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.
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?
17-Item Hamilton Depression Rating Scale (HAM-D17) score (time frame: Week 1, 2, 4 and 6). 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 21 May 2014.