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

Primary Purpose

Major Depressive Disorder (MDD)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MSI-195
Placebo
Sponsored by
MSI Methylation Sciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder (MDD) focused on measuring Depressive Disorder

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI INvestigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site
  • MSI Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MSI-195

Placebo

Arm Description

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)

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
Adverse events
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)
administered by qualified clinician

Full Information

First Posted
July 26, 2013
Last Updated
March 17, 2016
Sponsor
MSI Methylation Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01912196
Brief Title
Add-On Study of MSI-195 (S-Adenosyl-L-Methionine, SAMe) for Patients With Major Depressive Disorder (MDD)
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 Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MSI Methylation Sciences, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder (MDD)
Keywords
Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
376 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MSI-195
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
MSI-195
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in the total Hamilton Depression Rating Scale (HAM-D17) between randomization and end of study.
Description
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.
Time Frame
assessed from baseline to week 8 (end of study)
Secondary Outcome Measure Information:
Title
change in the total score of the Montgomery-Asberg Depression Rating Scale (MADRS)
Description
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).
Time Frame
collected at baseline, weeks 2, 4, 6, 7 and 8 (end of study)
Title
change in total score of the Clinical Global Impression Improvement Scale (CGI-S)
Description
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.
Time Frame
assessed from baseline, weeks 2, 4, 7 and 8 (end of study)
Title
change from randomization to each study visit in the total score of the Inventory of Depressive Symptomatology-Self Rated (IDS-SR30)
Description
A response is defined as a reduction in the IDS-SR30 score of ≥50% and remission is defined as a score of ≤14.
Time Frame
assessed on baseline visit, Week 2, 4, 6, and 8 (end of study).
Title
Adverse events
Description
collected from signing informed consent through 7 days after the last dose of study treatment. Ascertained by qualified clinician.
Time Frame
collected at baseline, weeks 1, 2, 3, 4, 6, 8 and 9 (follow up)
Title
Columbia Suicide Severity Rating Scale (C-SSRS)
Description
administered by qualified clinician
Time Frame
assessed at baseline, weeks 2, 4, 6 and 8 (end of study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
MSI Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
MSI Investigational Site
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
MSI Investigational Site
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
MSI Investigational Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
MSI Investigational Site
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
MSI Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
MSI Investigational Site
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
MSI Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
MSI Investigational Site
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
MSI Investigational Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
MSI Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
MSI Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
MSI INvestigational Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
MSI Investigational Site
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
MSI Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
MSI Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
MSI Investigational Site
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
MSI Investigational Site
City
Towson
State/Province
Maryland
ZIP/Postal Code
21285
Country
United States
Facility Name
MSI Investigational Site
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
MSI Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
MSI Investigational Site
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
MSI Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
MSI Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
MSI Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
MSI Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
MSI Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
MSI Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
MSI Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
MSI Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
MSI Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
MSI Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
MSI Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
MSI Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
MSI Investigational Site
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
MSI Investigational Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30368163
Citation
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.
Results Reference
derived

Learn more about this trial

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

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