Clinical trial NCT01912196: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder (MDD)
Keywords: Depressive Disorder
Lead sponsor: MSI Methylation Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-31
Enrollment: 376
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in the total Hamilton Depression Rating Scale (HAM-D17) between randomization and end of study.
timeFrame: assessed from baseline to week 8 (end of study)
Secondary outcomes:
measure: change in the total score of the Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: collected at baseline, weeks 2, 4, 6, 7 and 8 (end of study)
measure: change in total score of the Clinical Global Impression Improvement Scale (CGI-S)
timeFrame: assessed from baseline, weeks 2, 4, 7 and 8 (end of study)
measure: change from randomization to each study visit in the total score of the Inventory of Depressive Symptomatology-Self Rated (IDS-SR30)
timeFrame: assessed on baseline visit, Week 2, 4, 6, and 8 (end of study).
measure: Adverse events
timeFrame: collected at baseline, weeks 1, 2, 3, 4, 6, 8 and 9 (follow up)
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: assessed at baseline, weeks 2, 4, 6 and 8 (end of study)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: MSI Investigational Site
state: Alabama
city: Encino
country: United States
facility: MSI Investigational Site
state: California
city: Escondido
country: United States
facility: MSI Investigational Site
state: California
city: Garden Grove
country: United States
facility: MSI Investigational Site
state: California
city: Los Alamitos
country: United States
facility: MSI Investigational Site
state: California
city: Los Angeles
country: United States
facility: MSI Investigational Site
state: California
city: National City
country: United States
facility: MSI Investigational Site
state: California
city: Newport Beach
country: United States
facility: MSI Investigational Site
state: California
city: Oakland
country: United States
facility: MSI Investigational Site
state: California
city: Oceanside
country: United States
facility: MSI Investigational Site
state: California
city: Torrance
country: United States
facility: MSI Investigational Site
state: California
city: Jacksonville
country: United States
facility: MSI Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: MSI INvestigational Site
state: Florida
city: Lauderhill
country: United States
facility: MSI Investigational Site
state: Florida
city: Orlando
country: United States
facility: MSI Investigational Site
state: Florida
city: Atlanta
country: United States
facility: MSI Investigational Site
state: Georgia
city: Hoffman Estates
country: United States
facility: MSI Investigational Site
state: Illinois
city: Towson
country: United States
facility: MSI Investigational Site
state: Maryland
city: Flowood
country: United States
facility: MSI Investigational Site
state: Mississippi
city: Las Vegas
country: United States
facility: MSI Investigational Site
state: Nevada
city: Marlton
country: United States
facility: MSI Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: MSI Investigational Site
state: New Mexico
city: New York
country: United States
facility: MSI Investigational Site
state: New York
city: Rochester
country: United States
facility: MSI Investigational Site
state: New York
city: Canton
country: United States
facility: MSI Investigational Site
state: Ohio
city: Dayton
country: United States
facility: MSI Investigational Site
state: Ohio
city: Portland
country: United States
facility: MSI Investigational Site
state: Oregon
city: Memphis
country: United States
facility: MSI Investigational Site
state: Tennessee
city: Austin
country: United States
facility: MSI Investigational Site
state: Texas
city: Austin
country: United States
facility: MSI Investigational Site
state: Texas
city: Dallas
country: United States
facility: MSI Investigational Site
state: Texas
city: Houston
country: United States
facility: MSI Investigational Site
state: Texas
city: Houston
country: United States
facility: MSI Investigational Site
state: Texas
city: Murray
country: United States
facility: MSI Investigational Site
state: Utah
city: Bellevue
country: United States
facility: MSI Investigational Site
state: Washington
Study officials:
References:
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.