Clinical trial NCT01437657: MARIGOLD Study: A Study of RO4917523 Versus Placebo as Adjunctive Therapy in Patients With Major Depressive Disorder and an Inadequate Response to Ongoing Antidepressant Therapy
Official title: A Randomized, Double-blind, Parallel-group Study of the Safety and Efficacy of RO4917523 Versus Placebo, as Adjunctive Therapy in Patients With Major Depressive Disorder With Inadequate Response to Ongoing Antidepressant Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-09-21
Enrollment: 319
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety and efficacy of RO4917523 as adjunctive therapy in patients with major depressive disorder and an inadequate response to ongoing antidepressant therapy. Anticipated time on study treatment is 6 weeks with a 3-week follow-up.


Eligibility criteria: Inclusion Criteria:

* Adult patient, 18 to 70 years of age at time of informed consent
* Major depressive disorder without psychotic features as defined by DSM-IV-TR criteria
* Inadequate response to ongoing antidepressant treatment, as defined by protocol
* Body mass index (BMI) 18 to 38 kg/m2 inclusive

Exclusion Criteria:

* Currently receiving treatment with a combination of antidepressants (two or more), or an adjunctive potentiating treatment as defined by protocol
* Previously received RO4917523
* History of failure, or utilization during the current episode of Electroconvulsive Therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS)
* History of use at any time of Vagus Nerve Stimulation (VNS) or Deep Brain Stimulation (DBS)
* Current or past history of bipolar disorder (e.g. manic, hypomanic, or mixed episodes)
* Pregnant or lactating women

Primary outcomes:
measure: Change in Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: From baseline to Week 6
Secondary outcomes:
measure: Change in Clinical Global Impression Score - Severity (CGI-S)
timeFrame: From baseline to Week 6
measure: Change in Clinical Global Impression Score - Improvement (CGI-I)
timeFrame: From baseline to Week 6
measure: Safety: Incidence of adverse events
timeFrame: approximately 2 years
measure: Proportion of patients exhibiting remission (MADRS </= 10) after 6 weeks of treatment
timeFrame: approximately 2 years
measure: Proportion of patients exhibiting response (reduction in MADRS >/= 50% of baseline score) after 6 weeks of treatment
timeFrame: approximately 2 years
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Costa Mesa
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Orange
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Wildomar
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: Libertyville
country: United States
state: Illinois
city: Naperville
country: United States
state: Illinois
city: Oak Brook
country: United States
state: Illinois
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Las Vegas
country: United States
state: Nevada
city: Marlton
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Cedarhurst
country: United States
state: New York
city: Oklahoma City
country: United States
state: Oklahoma
city: Norristown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Kirkland
country: United States
state: Washington
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Temuco
country: Chile
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Freiburg
country: Germany
city: Hannover
country: Germany
city: Mainz
country: Germany
city: Wiesbaden
country: Germany
city: Chuo-ku
country: Japan
city: Hokkaido
country: Japan
city: Hyogo
country: Japan
city: Kanagawa
country: Japan
city: Kanagawa
country: Japan
city: Kita-Ku
country: Japan
city: Kurayoshi-shi
country: Japan
city: Kyoto
country: Japan
city: Osaka
country: Japan
city: Shinjuku-ku
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Aguascalientes
country: Mexico
city: Leon
country: Mexico
city: Monterrey
country: Mexico
city: Belchatow
country: Poland
city: Bialystok
country: Poland
city: Bialystok
country: Poland
city: Choroszcz
country: Poland
city: Kielce
country: Poland
city: Lodz
country: Poland
city: Tuszyn
country: Poland
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Constanta
country: Romania
city: Craiova
country: Romania
city: Targouiste
country: Romania
city: Targu Mures
country: Romania
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Keelung
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Quiroz JA, Tamburri P, Deptula D, Banken L, Beyer U, Rabbia M, Parkar N, Fontoura P, Santarelli L. Efficacy and Safety of Basimglurant as Adjunctive Therapy for Major Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jul 1;73(7):675-84. doi: 10.1001/jamapsychiatry.2016.0838.