Add-On Study of MSI-195 (S-Adenosyl-L-Methionine, SAMe) for Patients With Major Depressive Disorder (MDD)

NCT01912196 | Completed Phase 2 DMC

• 1 other identifier: MSI-CP.002
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 35

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.

Conditions

Major Depressive Disorder (MDD)

Keywords

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• 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)

• 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)

• 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).

• Adverse events

  collected at baseline, weeks 1, 2, 3, 4, 6, 8 and 9 (follow up)

• Columbia Suicide Severity Rating Scale (C-SSRS)

  assessed at baseline, weeks 2, 4, 6 and 8 (end of study)

Study Arms (2)

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)

Drug: MSI-195

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).

Drug: Placebo

Interventions

MSI-195 DRUG

MSI-195

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• MSI Methylation Sciences, Inc.: lead

Study Sites (35)

MSI Investigational Site

Birmingham, Alabama, 35216, United States

Location

MSI Investigational Site

Encino, California, 91316, United States

Location

MSI Investigational Site

Escondido, California, 92025, United States

Location

MSI Investigational Site

Garden Grove, California, 92845, United States

Location

MSI Investigational Site

Los Alamitos, California, 90720, United States

Location

MSI Investigational Site

Los Angeles, California, 90024, United States

Location

MSI Investigational Site

National City, California, 91950, United States

Location

MSI Investigational Site

Newport Beach, California, 92660, United States

Location

MSI Investigational Site

Oakland, California, 94612, United States

Location

MSI Investigational Site

Oceanside, California, 92056, United States

Location

MSI Investigational Site

Torrance, California, 90502, United States

Location

MSI Investigational Site

Jacksonville, Florida, 32256, United States

Location

MSI INvestigational Site

Kissimmee, Florida, 34741, United States

Location

MSI Investigational Site

Lauderhill, Florida, 33319, United States

Location

MSI Investigational Site

Orlando, Florida, 32806, United States

Location

MSI Investigational Site

Atlanta, Georgia, 30328, United States

Location

MSI Investigational Site

Hoffman Estates, Illinois, 60169, United States

Location

MSI Investigational Site

Towson, Maryland, 21285, United States

Location

MSI Investigational Site

Flowood, Mississippi, 39232, United States

Location

MSI Investigational Site

Las Vegas, Nevada, 89102, United States

Location

MSI Investigational Site

Marlton, New Jersey, 08053, United States

Location

MSI Investigational Site

Albuquerque, New Mexico, 87109, United States

Location

MSI Investigational Site

New York, New York, 10128, United States

Location

MSI Investigational Site

Rochester, New York, 14618, United States

Location

MSI Investigational Site

Canton, Ohio, 44718, United States

Location

MSI Investigational Site

Dayton, Ohio, 45417, United States

Location

MSI Investigational Site

Portland, Oregon, 97210, United States

Location

MSI Investigational Site

Memphis, Tennessee, 38119, United States

Location

MSI Investigational Site

Austin, Texas, 78731, United States

Location

MSI Investigational Site

Austin, Texas, 78754, United States

Location

MSI Investigational Site

Dallas, Texas, 75231, United States

Location

MSI Investigational Site

Houston, Texas, 77008, United States

Location

MSI Investigational Site

Houston, Texas, 77098, United States

Location

MSI Investigational Site

Murray, Utah, 84123, United States

Location

MSI Investigational Site

Bellevue, Washington, 98007, United States

Location

Related Publications (1)

• 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.

  PMID: 30368163 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: July 31, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 18, 2016

Record last verified: 2016-03

Locations

US (35)