Major Depressive Disorder (MDD) MedDRA version: 9.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS
Conditions
Interventions
Product Code: SA4503 1 mg
Pharmaceutical Form: Capsule, hard
Current Sponsor code: SA4503
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of
Sponsors
M's Science Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female between the ages of 18 and 65 (inclusive). 2. Diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria and a shortened MINI evaluation. 3. HAM-D17 score of equal or more than 21 and a severity score of at least 2 for Item 1 (depressed mood) at both Screening and Baseline. 4. Current depressive episode of at least 3 months duration, and significant depressed mood and anhedonia in the 4 weeks prior to Screening. 5. Ability to understand the requirements of the study. 6. Willingness to adhere to the study requirements, to return for required assessments, and to give informed consent. 7. No clinically significant abnormalities in safety laboratory measurements as judged by the Investigator.. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects who, in the opinion of the Investigator, represent a significant risk of harming themselves or others, or who otherwise require special surveillance. 2. Subjects with a history of seizure or who have been treated with anticonvulsants for seizures. 3. Subjects who have family history of seizure or epilepsy (first degree family) 4. Subjects who have history of recent head trauma or any loss of consciousness in a 12-year period 5. Subjects who have participated in a clinical trial with any unlicensed medication in the 30 days prior to Screening, or subjects who have participated in a clinical trial with an approved or unlicensed antidepressant in the 3 months prior to Screening. 6. Subjects who have received fluoxetine within one month prior to Baseline or any other antidepressant within 2 weeks prior to Baseline, or any unlicenced medication within 1 month before the Screening. 7. Subjects who require psychotropic medication other than the study medication. 8. Subjects who started psychotherapy within 4 months prior to Screening, or are planning to do so at any time during the study. 9. Subjects who received electroconvulsive therapy (ECT) or Lithium therapy within 3 months prior to Screening 10. 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. 11. Subjects who have a primary diagnosis of anxiety. 12. Subjects who regularly use sleeping medication more than 3 times per week, or who use benzodiazepines. 13. Subjects who have major psychiatric or neurologic disorders other than MDD. 14. Subjects with depression secondary to stroke, cancer, or other severe medical illness. 15. Subjects who have a history (within 1 year prior to Screening) of alcohol or substance dependence, with the exception of nicotine or caffeine dependence. 16. Subjects with clinically significant cardiovascular disease, allergic sensitivities to relevant drug and/or food ingredients (including severe lactose intolerance), or other clinically significant medical comorbidities that might pose a safety risk, interfere with the absorption or metabolism of the study medication, or limit interpretation of the trial results. 17. Women who are pregnant or lactating. 18. Subjects with reproductive potential who do not agree to use adequate contraception (hormonal contraception or Intra Uterine Device together with a barrier method) throughout the study. 19. Subjects who carry PM (poor metabolizer) genotype for CYP2D6. 20. Subjects with primary diagnosis for seasonal affective disorder (SAD), i.e. SAD symptoms in 2 consecutive winters, no symptoms at summertime. 21. Subjects with borderline personality disorder. 22. Subjects with hyper or hypothyroidism, except subjects who receive adequate therapy for this condition and their medication has remained stable during the last 12 months before Screening, and who have normal blood TSH and free T4 levels at Screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of SA4503 (1 mg and 3 mg) compared to placebo in the treatment of subjects with MDD.;Secondary Objective: To evaluate the safety of SA4503 (1 mg and 3 mg) compared to placebo in subjects with MDD.;Primary end point(s): The primary efficacy variable is the change from Baseline to Week 8 in MADRS score. | — |
Countries
Estonia, Finland, Latvia, Lithuania
Outcome results
None listed