None listed
Conditions
Brief summary
Multi-centre Phase 2a open-labelled extension study of R-107 in MDD treatment resistant subjects who responded to treatment in the R107-C205 (BEDROC) study. Each subject will participate in up to 3 phases: • A screening phase of up to 3 weeks • An open-label treatment phase for 24 weeks • A 4-week post-treatment (follow up) phase
Interventions
Extended Release R-107 oral tablets (60 mg). Subjects will be dosed initially with 120mg (2 x 60mg tablets) twice a week. Subjects will be assessed for response at each scheduled clinic visit and may increase the dose to 180mg (3 x 60mg tablets) twice a week or decrease the dose to 60mg (1 x 60mg tablet) twice a week. All participants will be provided with guidance on how and when to take their study drug dose. All participants will also be given a Reminder Card informing them to take the tablet
Extended Release R-107 oral tablets (60 mg). Subjects will be dosed initially with 120mg (2 x 60mg tablets) twice a week. Subjects will be assessed for response at each scheduled clinic visit and may increase the dose to 180mg (3 x 60mg tablets) twice a week or decrease the dose to 60mg (1 x 60mg tablet) twice a week. All participants will be provided with guidance on how and when to take their study drug dose. All participants will also be given a Reminder Card informing them to take the tablets twice a week on days 1 and 4. Subjects will continue treatment for 24 weeks or until they meet withdrawal criteria. Subjects will be required to returned all study drug bottles for compliance assessments. A subject will be withdrawn from the study for any of the following reasons: • Lost to follow-up; • Withdrawal of consent; • Violation of protocol procedures (determined on a case by case basis); • The subject becomes pregnant. Subjects showing clinically significant worsening of symptoms (as measured through change in MADRS, CADSS, C-SSRS, BPIC-SS score) will be immediately withdrawn from the study if: • MADRS score greater or equal to 22 OR • The Principal Investigator sees fit that a subject is withdrawn because of significant tolerability and/or safety issues.
Sponsors
Douglas Pharmaceuticals Ltd.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 81 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following criteria: 1. Provision of written informed consent prior to any study specific procedures 2. Female or male subjects aged 18-81 years inclusive at the time of enrolment (Screening visit). 3. Enrolled into the double-blind treatment phase of the R107-C205 (BEDROC) study. 4. Met relapse criteria at or before Day 92 of the R107-C205 study; or have completed the R107-C205 study. 5. Treatment resistance in major depression defined as lack of clinically meaningful improvement despite the use of adequate doses of at least two antidepressant agents, derived from the group(s) of commonly used first line treatment, prescribed for adequate duration with adequate affirmation of treatment adherence.
Exclusion criteria
Subjects must NOT meet any of the following exclusion criteria to be enrolled: 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 patient at risk because of participation in the study, or may influence the results of the study, or the patient’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 patient at risk or negatively affect the outcome of the study. 4. 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). 5. Significant current risk of suicide
Outcome results
None listed