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

Major Depressive Disorder (MDD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912196
• Other study ID #: MSI-CP.002
• Status: Completed
• Phase: Phase 2
• First received: July 26, 2013
• Last updated: March 17, 2016
• Start date: October 2013
• Est. completion date: September 2015

Study information

• Verified date: March 2016
• Source: MSI Methylation Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder (MDD)

Intervention

Drug:
• MSI-195

• Placebo

Locations

Country	Name	City	State
United States	MSI Investigational Site	Albuquerque	New Mexico
United States	MSI Investigational Site	Atlanta	Georgia
United States	MSI Investigational Site	Austin	Texas
United States	MSI Investigational Site	Austin	Texas
United States	MSI Investigational Site	Bellevue	Washington
United States	MSI Investigational Site	Birmingham	Alabama
United States	MSI Investigational Site	Canton	Ohio
United States	MSI Investigational Site	Dallas	Texas
United States	MSI Investigational Site	Dayton	Ohio
United States	MSI Investigational Site	Encino	California
United States	MSI Investigational Site	Escondido	California
United States	MSI Investigational Site	Flowood	Mississippi
United States	MSI Investigational Site	Garden Grove	California
United States	MSI Investigational Site	Hoffman Estates	Illinois
United States	MSI Investigational Site	Houston	Texas
United States	MSI Investigational Site	Houston	Texas
United States	MSI Investigational Site	Jacksonville	Florida
United States	MSI INvestigational Site	Kissimmee	Florida
United States	MSI Investigational Site	Las Vegas	Nevada
United States	MSI Investigational Site	Lauderhill	Florida
United States	MSI Investigational Site	Los Alamitos	California
United States	MSI Investigational Site	Los Angeles	California
United States	MSI Investigational Site	Marlton	New Jersey
United States	MSI Investigational Site	Memphis	Tennessee
United States	MSI Investigational Site	Murray	Utah
United States	MSI Investigational Site	National City	California
United States	MSI Investigational Site	New York	New York
United States	MSI Investigational Site	Newport Beach	California
United States	MSI Investigational Site	Oakland	California
United States	MSI Investigational Site	Oceanside	California
United States	MSI Investigational Site	Orlando	Florida
United States	MSI Investigational Site	Portland	Oregon
United States	MSI Investigational Site	Rochester	New York
United States	MSI Investigational Site	Torrance	California
United States	MSI Investigational Site	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
MSI Methylation Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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).	collected at baseline, weeks 2, 4, 6, 7 and 8 (end of study)	No
Secondary	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)	No
Secondary	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).	No
Secondary	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)	Yes
Secondary	Columbia Suicide Severity Rating Scale (C-SSRS)	administered by qualified clinician	assessed at baseline, weeks 2, 4, 6 and 8 (end of study)	No