A Phase 2 clinical study evaluating the efficacy and safety of R-107 for the Treatment of treatment-resistant depression.
- Conditions
- Major Depressive DisorderMental Health - Depression
- Registration Number
- ACTRN12618001042235
- Lead Sponsor
- Douglas Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 168
1. Provision of written informed consent prior to any study specific procedures;
2. Subjects aged 18-80 years inclusive at the time of enrolment (screening visit);
3. Diagnosed with MDD as per Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) and Mini-International Neuropsychiatric Interview (MINI) 7.0 without psychotic features for at least three months prior to screening (comorbid anxiety disorders are also acceptable);
4. Montgomery Asberg Depression Rating Scale (MADRS) total score of greater than or equal to 20 at screening and baseline;
5. Treatment resistance in major depression (TRD) as per Maudsley Staging Method (MSM) and defined as failure to attain significant level of improvement (equated with clinical remission) from an accurately defined depressive episode following treatment with an antidepressant medication given at an adequate (minimum effective) dose for a minimum of six weeks”;
6. Montreal Cognitive Assessment (MoCA) score greater than or equal to 26 assessing cognitive function;
7. Psychotropic medication and/or psychotherapy is stable (i.e. no change of drugs or drug dose or visit schedule within 4 weeks prior to Day 1/baseline);
8. Subjects must weigh at least 50kg and have a Body Mass Index (BMI) between 18 and 40 kg/m2 inclusive;
9. Subjects of childbearing potential (SOCBP) must use a highly effective form of birth control .
1.Any significant disease or disorder (e.g., cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject’s ability to participate in the study;
2.Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening and at baseline, which in the opinion of the Investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject’s ability to complete entire duration of the study.
3.Any ECG abnormality obtained during the screening period that in Investigator’s judgement may put the subject at risk or negatively affect the outcome of the study;
4.Subjects are excluded if they have any of the following:
•A history of known immunodeficiency disorder including a positive test for human immunodeficiency virus, HIV-1 or HIV-2;
•Positive hepatitis B surface antigen, or positive hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enrol.
5.Hepatic Insufficiency: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level greater than or equal to 2 times the upper limit of normal (ULN) confirmed by repeated testing during screening period;
6.Pregnant, breastfeeding, or lactating women (Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1);
7.Significant current risk of suicide.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of extended release (ER) R-107 tablets (30mg, 60mg, 120mg, 180mg) as measured by the change in Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline (Day 1) to Day 92 in subjects with Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) Treatment-Resistant Depression (TRD) who have responded to 1 weeks’ treatment with R-107 120mg tablets.[The MADRS will be assessed at Days 1, 5, 8, 15, 22, 29, 36, 64 and Day 92 (primary endpoint).]
- Secondary Outcome Measures
Name Time Method To assess the effect of R-107 tablets compared to placebo on the severity of illness using the Clinician Global Impression – Severity (CGI-S).[Days 1, 8, 36, 64 and 92. Also assess at 4 week follow up visit.];To evaluate the pharmacokinetics (PK) of R-107 tablets in subjects with TRD where Tmax, AUC and T1/2 will be assessed.[Days 8, 64 and 92];To assess the effect of R-107 tablets compared to placebo on the severity of illness using the Patient Global Impression – Severity (PGI-S).[Days 1, 8, 36, 64 and 92. Also assess at 4 week follow up visit.]