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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSI-195 | Experimental | Patients randomized to the MSI-195 arm will receive treatment with 2 tablets (800 mg) of MSI-195 plus on-going antidepressant therapy (ADT). MSI-195 800 mg (two tablets) taken orally once a day in the morning on an empty stomach with water (food should be avoided for at least 1 hr after taking the study drug) |
|
| Placebo | Placebo Comparator | Patients randomized to the placebo arm will receive 2 tablets placebo plus on-going antidepressant therapy (ADT). Placebo (two tablets) taken orally once a day in the morning on an empty stomach with water (food should be avoided for at least 1 hr after taking the study drug). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSI-195 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the total Hamilton Depression Rating Scale (HAM-D17) between randomization and 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. | assessed from baseline to week 8 (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| change in the total score of the Montgomery-Asberg Depression Rating Scale (MADRS) | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MSI Investigational Site | Birmingham | Alabama | 35216 | United States | ||
| MSI Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30368163 | Derived | Targum SD, Cameron BR, Ferreira L, MacDonald ID. An augmentation study of MSI-195 (S-adenosylmethionine) in Major Depressive Disorder. J Psychiatr Res. 2018 Dec;107:86-96. doi: 10.1016/j.jpsychires.2018.10.010. Epub 2018 Oct 18. |
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|
| collected at baseline, weeks 2, 4, 6, 7 and 8 (end of study) |
| change in total score of the Clinical Global Impression Improvement Scale (CGI-S) | 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. | assessed from baseline, weeks 2, 4, 7 and 8 (end of study) |
| change from randomization to each study visit in the total score of the Inventory of Depressive Symptomatology-Self Rated (IDS-SR30) | A response is defined as a reduction in the IDS-SR30 score of ≥50% and remission is defined as a score of ≤14. | assessed on baseline visit, Week 2, 4, 6, and 8 (end of study). |
| Adverse events | collected from signing informed consent through 7 days after the last dose of study treatment. Ascertained by qualified clinician. | collected at baseline, weeks 1, 2, 3, 4, 6, 8 and 9 (follow up) |
| Columbia Suicide Severity Rating Scale (C-SSRS) | administered by qualified clinician | assessed at baseline, weeks 2, 4, 6 and 8 (end of study) |
| Encino |
| California |
| 91316 |
| United States |
| MSI Investigational Site | Escondido | California | 92025 | United States |
| MSI Investigational Site | Garden Grove | California | 92845 | United States |
| MSI Investigational Site | Los Alamitos | California | 90720 | United States |
| MSI Investigational Site | Los Angeles | California | 90024 | United States |
| MSI Investigational Site | National City | California | 91950 | United States |
| MSI Investigational Site | Newport Beach | California | 92660 | United States |
| MSI Investigational Site | Oakland | California | 94612 | United States |
| MSI Investigational Site | Oceanside | California | 92056 | United States |
| MSI Investigational Site | Torrance | California | 90502 | United States |
| MSI Investigational Site | Jacksonville | Florida | 32256 | United States |
| MSI INvestigational Site | Kissimmee | Florida | 34741 | United States |
| MSI Investigational Site | Lauderhill | Florida | 33319 | United States |
| MSI Investigational Site | Orlando | Florida | 32806 | United States |
| MSI Investigational Site | Atlanta | Georgia | 30328 | United States |
| MSI Investigational Site | Hoffman Estates | Illinois | 60169 | United States |
| MSI Investigational Site | Towson | Maryland | 21285 | United States |
| MSI Investigational Site | Flowood | Mississippi | 39232 | United States |
| MSI Investigational Site | Las Vegas | Nevada | 89102 | United States |
| MSI Investigational Site | Marlton | New Jersey | 08053 | United States |
| MSI Investigational Site | Albuquerque | New Mexico | 87109 | United States |
| MSI Investigational Site | New York | New York | 10128 | United States |
| MSI Investigational Site | Rochester | New York | 14618 | United States |
| MSI Investigational Site | Canton | Ohio | 44718 | United States |
| MSI Investigational Site | Dayton | Ohio | 45417 | United States |
| MSI Investigational Site | Portland | Oregon | 97210 | United States |
| MSI Investigational Site | Memphis | Tennessee | 38119 | United States |
| MSI Investigational Site | Austin | Texas | 78731 | United States |
| MSI Investigational Site | Austin | Texas | 78754 | United States |
| MSI Investigational Site | Dallas | Texas | 75231 | United States |
| MSI Investigational Site | Houston | Texas | 77008 | United States |
| MSI Investigational Site | Houston | Texas | 77098 | United States |
| MSI Investigational Site | Murray | Utah | 84123 | United States |
| MSI Investigational Site | Bellevue | Washington | 98007 | United States |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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