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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by MSI Methylation Sciences, Inc.
Sponsor:
Information provided by (Responsible Party):
MSI Methylation Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT01912196
First received: July 26, 2013
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Major Depressive Disorder (MDD)
Drug: MSI-195
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by MSI Methylation Sciences, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) [ Time Frame: collected at baseline, weeks 2, 4, 6, 7 and 8 (end of study) ] [ Designated as safety issue: No ]
    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) [ Time Frame: assessed from baseline, weeks 2, 4, 7 and 8 (end of study) ] [ Designated as safety issue: No ]
    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) [ Time Frame: assessed on baseline visit, Week 2, 4, 6, and 8 (end of study). ] [ Designated as safety issue: No ]
    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 [ Time Frame: collected at baseline, weeks 1, 2, 3, 4, 6, 8 and 9 (follow up) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: assessed at baseline, weeks 2, 4, 6 and 8 (end of study) ] [ Designated as safety issue: No ]
    administered by qualified clinician


Estimated Enrollment: 286
Study Start Date: October 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912196

Contacts
Contact: Scott Smith, PM 512-913-6731 scott.smith@ppdi.com

  Show 38 Study Locations
Sponsors and Collaborators
MSI Methylation Sciences, Inc.
  More Information

No publications provided

Responsible Party: MSI Methylation Sciences, Inc.
ClinicalTrials.gov Identifier: NCT01912196     History of Changes
Other Study ID Numbers: MSI-CP.002
Study First Received: July 26, 2013
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by MSI Methylation Sciences, Inc.:
Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014