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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01912196
Recruitment Status : Completed
First Posted : July 31, 2013
Last Update Posted : March 18, 2016
Sponsor:
Information provided by (Responsible Party):
MSI Methylation Sciences, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder (MDD) Drug: MSI-195 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Randomized Add-On Study of MSI-195 (Methylation Sciences Inc. S-Adenosyl-L-Methionine, SAMe) For Patients With Major Depressive Disorder(MDD) Who Have Had An Inadequate Response to Current Antidepressant Therapy
Study Start Date : October 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MSI-195

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 Comparator: Placebo

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


Outcome Measures
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Primary Outcome Measures :
  1. Change in the total Hamilton Depression Rating Scale (HAM-D17) between randomization and end of study. [ Time Frame: 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 Outcome Measures :
  1. change in the total score of the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 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).

  2. change in total score of the Clinical Global Impression Improvement Scale (CGI-S) [ Time Frame: 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.

  3. change from randomization to each study visit in the total score of the Inventory of Depressive Symptomatology-Self Rated (IDS-SR30) [ Time Frame: 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.

  4. Adverse events [ Time Frame: 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.

  5. Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: assessed at baseline, weeks 2, 4, 6 and 8 (end of study) ]
    administered by qualified clinician


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912196


Locations
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United States, Alabama
MSI Investigational Site
Birmingham, Alabama, United States, 35216
United States, California
MSI Investigational Site
Encino, California, United States, 91316
MSI Investigational Site
Escondido, California, United States, 92025
MSI Investigational Site
Garden Grove, California, United States, 92845
MSI Investigational Site
Los Alamitos, California, United States, 90720
MSI Investigational Site
Los Angeles, California, United States, 90024
MSI Investigational Site
National City, California, United States, 91950
MSI Investigational Site
Newport Beach, California, United States, 92660
MSI Investigational Site
Oakland, California, United States, 94612
MSI Investigational Site
Oceanside, California, United States, 92056
MSI Investigational Site
Torrance, California, United States, 90502
United States, Florida
MSI Investigational Site
Jacksonville, Florida, United States, 32256
MSI INvestigational Site
Kissimmee, Florida, United States, 34741
MSI Investigational Site
Lauderhill, Florida, United States, 33319
MSI Investigational Site
Orlando, Florida, United States, 32806
United States, Georgia
MSI Investigational Site
Atlanta, Georgia, United States, 30328
United States, Illinois
MSI Investigational Site
Hoffman Estates, Illinois, United States, 60169
United States, Maryland
MSI Investigational Site
Towson, Maryland, United States, 21285
United States, Mississippi
MSI Investigational Site
Flowood, Mississippi, United States, 39232
United States, Nevada
MSI Investigational Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
MSI Investigational Site
Marlton, New Jersey, United States, 08053
United States, New Mexico
MSI Investigational Site
Albuquerque, New Mexico, United States, 87109
United States, New York
MSI Investigational Site
New York, New York, United States, 10128
MSI Investigational Site
Rochester, New York, United States, 14618
United States, Ohio
MSI Investigational Site
Canton, Ohio, United States, 44718
MSI Investigational Site
Dayton, Ohio, United States, 45417
United States, Oregon
MSI Investigational Site
Portland, Oregon, United States, 97210
United States, Tennessee
MSI Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
MSI Investigational Site
Austin, Texas, United States, 78731
MSI Investigational Site
Austin, Texas, United States, 78754
MSI Investigational Site
Dallas, Texas, United States, 75231
MSI Investigational Site
Houston, Texas, United States, 77008
MSI Investigational Site
Houston, Texas, United States, 77098
United States, Utah
MSI Investigational Site
Murray, Utah, United States, 84123
United States, Washington
MSI Investigational Site
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
MSI Methylation Sciences, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: MSI Methylation Sciences, Inc.
ClinicalTrials.gov Identifier: NCT01912196    
Other Study ID Numbers: MSI-CP.002
First Posted: July 31, 2013    Key Record Dates
Last Update Posted: March 18, 2016
Last Verified: March 2016
Keywords provided by MSI Methylation Sciences, Inc.:
Depressive Disorder
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
 Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms