Depressive Disorder, MajorPhase 2NCT00551109
SA4503 8-Week Study in Major Depressive Disorder (MDD)
A Phase 2 study testing SA4503 Low and SA4503 High in people with Depressive Disorder, Major, run by M's Science Corporation at 5 sites in Finland.
Trial summary
The purpose of this study is to determine the efficacy of SA4503 compared to placebo in the treatment of subjects with major depressive disorder (MDD). Secondary, to evaluate the safety of SA4503 compared to placebo in subjects with MDD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- SA4503 Low and SA4503 High
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 5 sitesFinland
- Study dates
- Nov 2007to Sep 2008
- Phase
- Phase 2
- 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 between the ages of 18 and 65 (inclusive)
- Diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria and a shortened MINI evaluation
- HAM-D17 score of >/= 21 and a severity score of at least 2 for Item 1 (depressed mood) at both Screening and Baseline
- Current depressive episode of at least 3 months duration, and significant depressed mood and anhedonia in the 4 weeks prior to Screening.
Who cannot join
- Subjects who have received fluoxetine within 1 month prior to Baseline or any other antidepressant within 2 weeks prior to Baseline, or any unlicensed medication within 1 month before Screening
- Subjects who require psychotropic medication other than the study medication
- Subjects who started psychotherapy within 4 months prior to Screening
- Subjects who currently (i.e., in the month prior to Screening) meet DSM-IV criteria for bipolar syndrome or psychotic depression or severe somatoform or eating disorders
- Subjects who have a primary diagnosis of anxiety
- Subjects who regularly use sleeping medication more than 3 times per week
Show all 9Show fewer
- Subjects who have major psychiatric or neurologic disorders other than MDD
- Subjects with depression secondary to stroke, cancer, or other severe medical illness
- Subjects who have a history of alcohol or substance dependence(within 1 year prior to Screening)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Finland5 sites
Study site
Helsinki
Study site
Jyväskylä
Study site
Kuopio
Study site
Tampere
Study site
Turku
About this study
Official title: A Phase II, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Safety and Efficacy of Treatment With SA4503, Once Daily for 8 Weeks, in Subjects With Major Depressive Disorder
The purpose of this study is to determine the efficacy of SA4503 compared to placebo in the treatment of subjects with major depressive disorder (MDD). Secondary, to evaluate the safety of SA4503 compared to placebo in subjects with MDD.
Read the detailed description
Further study details as provided by M's Science Corporation:
- Conditions
- Depressive Disorder, Major
- Being tested
- placebo, SA4503 Low, SA4503 High
- 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.
placeboDrug
placebo, oral administration, once daily for 8 weeks
SA4503 LowDrug
Low dose, oral administration, once daily for 8 weeks
SA4503 HighDrug
High dose, oral administration, once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| P | Placebo comparator | Placebo Receives: Drug: placebo |
| A1 | Experimental | SA4503 Receives: Drug: SA4503 Low |
| A2 | Experimental | SA4503 Receives: Drug: SA4503 High |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale (MADRS)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startNov 2007
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M's Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Björn Appelberg, MD, PhD, Principal investigator, Helsinki University Central Hospital, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551109
- Sponsor's protocol ID
- ME1-1
- Other IDs
- EudraCT number: 2007-002740-16
- Status last verified
- Dec 2008
- First submitted
- 29 Oct 2007
- Last updated
- 18 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Safety and Efficacy of Treatment With SA4503, Once Daily for 8 Weeks, in Subjects With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00551109
- Acronym / sponsor ID
- ME1-1
- Conditions
- Depressive Disorder, Major
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- M's Science CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Study completion
- Sep 2008 (actual)
- First posted
- 30 Oct 2007 (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 purpose of this study is to determine the efficacy of SA4503 compared to placebo in the treatment of subjects with major depressive disorder (MDD). Secondary, to evaluate the safety of SA4503 compared to placebo in subjects with MDD.
Detailed description
Further study details as provided by M's Science Corporation:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| P | Placebo comparator | Drug: placeboPlacebo |
| A1 | Experimental | Drug: SA4503 LowSA4503 |
| A2 | Experimental | Drug: SA4503 HighSA4503 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female between the ages of 18 and 65 (inclusive)
- Diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria and a shortened MINI evaluation
- HAM-D17 score of >/= 21 and a severity score of at least 2 for Item 1 (depressed mood) at both Screening and Baseline
- Current depressive episode of at least 3 months duration, and significant depressed mood and anhedonia in the 4 weeks prior to Screening.
Key exclusion criteria (9 listed)
- Subjects who have received fluoxetine within 1 month prior to Baseline or any other antidepressant within 2 weeks prior to Baseline, or any unlicensed medication within 1 month before Screening
- Subjects who require psychotropic medication other than the study medication
- Subjects who started psychotherapy within 4 months prior to Screening
- Subjects who currently (i.e., in the month prior to Screening) meet DSM-IV criteria for bipolar syndrome or psychotic depression or severe somatoform or eating disorders
- Subjects who have a primary diagnosis of anxiety
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 |
|---|---|---|
| placeboplacebo, oral administration, once daily for 8 weeks | Drug | P |
| SA4503 LowLow dose, oral administration, once daily for 8 weeks | Drug | A1 |
| SA4503 HighHigh dose, oral administration, once daily for 8 weeks | Drug | A2 |
Primary outcome
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 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 18 Dec 2008.
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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.
Björn Appelberg, MD, PhD principal investigator
Helsinki University Central Hospital, Department of Psychiatry
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SA4503 Low and SA4503 High in people with Depressive Disorder, Major, run by M's Science Corporation at 5 sites in Finland.
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 4 inclusion and 9 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 18 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: 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 18 Dec 2008.