Major Depressive Disorder (MDD)
Conditions
Keywords
Depressive Disorder
Brief summary
The purpose of this study is to determine the efficacy and safety of 800 mg MSI-195 in reducing symptoms of depression in Major Depressive Disorder (MDD)patients with inadequate response to current antidepressant therapy.
Interventions
DRUGMSI-195
DRUGPlacebo
Sponsors
MSI Methylation Sciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Meets the Diagnostic and Statistical Manual of Mental Disorder, 4th Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD) * A total score of 16 or higher on the Hamilton Rating Scale for Depression- 17 item version (HAM-D17) at the Screening and Baseline Visits, with a score of ≥2 on mood item 1. * Have experienced 1-4 prior Major Depressive Episodes. Patients with more than 5 lifetime episodes (including current episode) will require discussion with the medical monitor prior to inclusion. * Failed 1-3 treatment regimens in the current depressive episode * Received an adequate dose and duration of Antidepressant Therapy (ADT) (on ADT for at least 6 weeks with a stable dose for at least 3 weeks)
Exclusion criteria
* Failed 4 or more adequate treatment regimens in current episode of depression * patient may have a significant risk for suicidal behavior during the course of their participation in the study * Intolerance to SAMe; Prior use of MSI-195 * History of any of the following psychiatric disorders: eating disorder within 6 months; obsessive compulsive disorder, psychotic disorder, bipolar disorder, mental retardation, dementia or other forms of cognitive impairment at any time or alcohol or substance abuse * \>3X upper limit of normal (ULN) Alkaline Phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT); \>1.5X ULN total bilirubin * Pregnant or lactating women * Any history of seizures, excluding febrile seizures * Known positivity for human immunodeficiency virus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the total Hamilton Depression Rating Scale (HAM-D17) between randomization and end of study. | assessed from baseline to week 8 (end of study) | Based on historical data, the standard deviation is assumed to range between 9 and 12. With a standard effect size of 0.367 a total of at least 120 evaluable patients per group are needed to provide 80% power with a two-sided 5% significance level. HAM-D17 will be derived from the Combined HAM-D28-MADRS Instrument. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in the total score of the Montgomery-Asberg Depression Rating Scale (MADRS) | collected at baseline, weeks 2, 4, 6, 7 and 8 (end of study) | for the MADRS, the number and proportion of patients who are responders at the end of the study and the number and proportion of patients who are in remission at the end of the study will be summarized by treatment group, along with the difference and 95% confidence interval for the difference (based on the Wilson Score method). |
| change in total score of the Clinical Global Impression Improvement Scale (CGI-S) | assessed from baseline, weeks 2, 4, 7 and 8 (end of study) | the number and proportion of patients who are responders at the end of the study and the number and proportion of patients who are in remission at the end of the study will be summarized by treatment group, along with the difference and 95% confidence interval for the difference (based on the Wilson Score method). Remission is defined as a score of 1 or 2. |
| change from randomization to each study visit in the total score of the Inventory of Depressive Symptomatology-Self Rated (IDS-SR30) | assessed on baseline visit, Week 2, 4, 6, and 8 (end of study). | A response is defined as a reduction in the IDS-SR30 score of ≥50% and remission is defined as a score of ≤14. |
| Adverse events | collected at baseline, weeks 1, 2, 3, 4, 6, 8 and 9 (follow up) | collected from signing informed consent through 7 days after the last dose of study treatment. Ascertained by qualified clinician. |
| Columbia Suicide Severity Rating Scale (C-SSRS) | assessed at baseline, weeks 2, 4, 6 and 8 (end of study) | administered by qualified clinician |
Countries
United States
Outcome results
None listed