Major Depressive DisorderNCT00873795
Compare the Efficacy and Tolerability of the Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitors (SSRIs) Used in Major Depression
A study testing aripiprazole , sertraline in people with Major Depressive Disorder, run by Chimei Medical Center at 1 site in Taiwan.
Trial summary
FDA has accepted atypical antipsychotics of olanzapine and aripiprazole as the adjuvant medications for refractory major depression. But there is still no trial about atypical antipsychotics combined with antidepressant of SSRI used in fresh major depressive patients. 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 , sertraline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2007to Mar 2009
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects 18 to 65 years inclusive.
- Fulfilled DSM-Ⅳ criteria for major depressive disorder.
- Onset ≧2 weeks.
- Baseline score ≧14 on the HAM-D17.
- Written informed consent prior to entry into the study.
Who cannot join
- HAM-D17 item 3 score≧3.
- Life-time history of bipolar disorders, schizophrenia or schizoaffective disorder.
- Current history of panic disorder, obsessive-compulsive disorder, alcohol or substance abuse.
- Mood disorder due to general medical condition.
- Treatment with antidepressants at entry into the study before 2 weeks.
- Need for psychoactive medications other than the study drugs, except for one benzodiazepine or hypnotic given at a stable dose.
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- Known intolerance or inefficacy to either drug.
- Previous lack of response to two or more antidepressants at adequate dosage.
- Subjects who have acute or unstable medical illness or organic failure.
- Pregnancy and breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Aripiprazole 2.5mg Combine Sertraline 50mg in Major Depression
FDA has accepted atypical antipsychotics of olanzapine and aripiprazole as the adjuvant medications for refractory major depression. But there is still no trial about atypical antipsychotics combined with antidepressant of SSRI used in fresh major depressive patients. This project aims to compare the efficacy and tolerability of sertraline with or without low-dosed aripiprazole added in fresh major depression.
Read the detailed description
This double-blind, placebo-control, fixed dose, randomized study will be conducted at a tertiary clinical setting. Patients over 18 y/o fulfilled DSM-IV criteria for major depression, having a baseline HAM-D score ≧ 14 and a HAM-D item 3 score < 3 will be recruited into the groups. The study group of patients will receive ten weeks of treatment with a combination of fix-dosed sertraline and aripiprazole. The control group will received sertraline only. The score reduction in HAM-D17, CGI, SF-36 and Brief Symptom Rating Scale (BSRS-50) will be periodically estimated as an efficacy following the use of a SSRIs or and aripiprazole.
- Conditions
- Major Depressive Disorder
- Being tested
- aripiprazole , sertraline
- Keywords
- efficacy, tolerability, combination of aripiprazole and SSRI(sertraline)
- 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 , sertralineDrug
In this ten weeks,double-blind,placebo-control,randomized,fixed dose study, study,subjects were randomly assigned to treatment with aripiprazole 2.5mg/day plus sertraline 50mg/day or sertraline 50mg/day plus placebo.
| Study group | Role | What they receive |
|---|---|---|
| aripiprazole and sertraline | Experimental | The patients of this arm receive ten weeks of treatment with a combination of sertraline 50mg/day and aripiprazole 2.5mg/day.The effect of this arm is assessed for HAM-D17, CGI, SF-36 and BSRS-50. Receives: Drug: aripiprazole , sertraline |
| sertraline and placebo | Placebo comparator | The patients of this arm receive ten weeks of treatment with a combination of sertraline 50mg/day and placebo.The effect of this arm is assessed for HAM-D17, CGI, SF-36 and BSRS-50. Receives: Drug: aripiprazole , sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
score change of Hamilton Rating Scale For Depression (HAM-D17 )
Measured: day 1 / 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10weeks
Secondary outcomes (1)
score change of Brief Psychiatric Rating Scale (BPRS-50)
Measured: day 1/ 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startApr 2007
- Primary completionMar 2009
- Study completionMar 2009
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chimei Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Fong-Lin Jang, M.D., Study director, Chimei Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873795
- Sponsor's protocol ID
- IRB 09603-001
- Status last verified
- Apr 2009
- First submitted
- 31 Mar 2009
- Last updated
- 2 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Aripiprazole 2.5mg Combine Sertraline 50mg in Major Depression
- ClinicalTrials.gov ID
- NCT00873795
- Acronym / sponsor ID
- IRB 09603-001
- Conditions
- Major Depressive Disorder
- Keywords
- efficacy, tolerability, combination of aripiprazole and SSRI(sertraline)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Chimei Medical CenterUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 2 Apr 2009 (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.
FDA has accepted atypical antipsychotics of olanzapine and aripiprazole as the adjuvant medications for refractory major depression. But there is still no trial about atypical antipsychotics combined with antidepressant of SSRI used in fresh major depressive patients. This project aims to compare the efficacy and tolerability of sertraline with or without low-dosed aripiprazole added in fresh major depression.
Detailed description
This double-blind, placebo-control, fixed dose, randomized study will be conducted at a tertiary clinical setting. Patients over 18 y/o fulfilled DSM-IV criteria for major depression, having a baseline HAM-D score ≧ 14 and a HAM-D item 3 score < 3 will be recruited into the groups. The study group of patients will receive ten weeks of treatment with a combination of fix-dosed sertraline and aripiprazole. The control group will received sertraline only. The score reduction in HAM-D17, CGI, SF-36 and Brief Symptom Rating Scale (BSRS-50) will be periodically estimated as an efficacy following the use of a SSRIs or and aripiprazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aripiprazole and sertraline | Experimental | Drug: aripiprazole , sertralineThe patients of this arm receive ten weeks of treatment with a combination of sertraline 50mg/day and aripiprazole 2.5mg/day.The effect of this arm is assessed for HAM-D17, CGI, SF-36 and BSRS-50. |
| sertraline and placebo | Placebo comparator | Drug: aripiprazole , sertralineThe patients of this arm receive ten weeks of treatment with a combination of sertraline 50mg/day and placebo.The effect of this arm is assessed for HAM-D17, CGI, SF-36 and BSRS-50. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects 18 to 65 years inclusive.
- Fulfilled DSM-Ⅳ criteria for major depressive disorder.
- Onset ≧2 weeks.
- Baseline score ≧14 on the HAM-D17.
- Written informed consent prior to entry into the study.
Key exclusion criteria (10 listed)
- HAM-D17 item 3 score≧3.
- Life-time history of bipolar disorders, schizophrenia or schizoaffective disorder.
- Current history of panic disorder, obsessive-compulsive disorder, alcohol or substance abuse.
- Mood disorder due to general medical condition.
- Treatment with antidepressants at entry into the study before 2 weeks.
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 , sertralineIn this ten weeks,double-blind,placebo-control,randomized,fixed dose study, study,subjects were randomly assigned to treatment with aripiprazole 2.5mg/day plus sertraline 50mg/day or sertraline 50mg/day plus placebo. | Drug | aripiprazole and sertraline, sertraline and placebo |
Primary outcome
score change of Hamilton Rating Scale For Depression (HAM-D17 )
Time frame: day 1 / 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10weeks
1 secondary outcome
score change of Brief Psychiatric Rating Scale (BPRS-50)
Time frame: day 1/ 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10 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 2 Apr 2009.
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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.
Fong-Lin Jang, M.D. study director
Chimei Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aripiprazole , sertraline in people with Major Depressive Disorder, run by Chimei Medical Center 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 10 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 2 Apr 2009. 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. Some participants in this study may receive a placebo. 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?
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?
score change of Hamilton Rating Scale For Depression (HAM-D17 ) (time frame: day 1 / 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10weeks). 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 2 Apr 2009.