Investigate Efficacy & Safety of RO4995819 vs. Placebo as Adjunct Tx in Patients w/Major Depressive Disorder

NCT01733654 | Withdrawn Phase 2 DMC

• 1 other identifier: 23708
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to explore the efficacy of 6 weeks treatment of an investigational medication, RO4995819, versus placebo as adjunctive therapy in patients with major depression.

Conditions

Depression; Major Depressive Disorder

Keywords

depression; major depressive disorder

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Depression Rating Scale

  The investigators hope to learn the efficacy of 6 weeks treatment of RO4995819 versus placebo as adjunctive therapy in patients with MDD having inadequate response to ongoing antidepressant treatment based on mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores from baseline to end of treatment. This knowledge is valuable because it is a new medication, which may have utility in the population of patients with major depressive disorder.

  6 weeks

Study Arms (4)

RO4995819 5mg

ACTIVE COMPARATOR

RO4995819 5mgX6wks

Biological: RO4995819

RO4995819 15mg

ACTIVE COMPARATOR

RO4995819 15mg X 6 weeks

Biological: RO4995819

RO4995819 30mg

ACTIVE COMPARATOR

RO4995819 30mg X 6 weeks

Biological: RO4995819

Placebo

PLACEBO COMPARATOR

Placebo X 6 weeks

Biological: RO4995819

Interventions

RO4995819 BIOLOGICAL

The investigation of RO4995819 as adjunctive therapy in MDD patients is supported by preclinical and clinical evidence implicating dysfunction of glutamatergic pathways in the pathophysiology of depression and cognitive disorders, and accumulated evidence of the antidepressant and procognitive effects of mGlu2/3 antagonism.

Also known as: RO4995819, 5mg, RO4995819, 15mg, RO4995819, 30mg, Placebo, (a pill that does not contain active drug)

Placebo; RO4995819 15mg; RO4995819 30mg; RO4995819 5mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are eligible for enrollment in this study if they meet all of the following criteria:
• An outpatient w/a primary diagnosis of major depressive disorder w/out psychotic features
• Inadequate response to current, ongoing antidepressant tx of SSRI/SNRI.
• Having at least 1 but no more than 2 antidepressant treatment failures w/in the index depressive episode
• Dose/duration of antidepressant treatment in index episode can be verified by documentation from one of following:
• Med records;
• Pharmacy records;
• Treating and/or referring physician (indicating medication, dose, dates of treatment).
• Documentation of clinical/treatment history must be available.
• Index depressive episode started w/in 1 year of screening.
• Confirmed compliance w/current SSRI/SNRI treatment based on blood screen.
• Existing med regimens should be stable for 6 wks prior to screening
• y.o. at time of consent
• BMI 18.0 to 35.0 kg/m2 inc.
• Patients w/reproductive potential must agree to use specified contraceptive protection during tx period and for at least 90 days after last dose of study drug:

You may not qualify if:

• Patients are excluded from this study if the answer is 'yes' to any of the following:
• Current and past treatment history:
• Currently receiving tx w/3 or more antidepressants.
• Currently receiving tx w/prohibited meds.
• Significant ongoing use of high doses of barbiturates, benzodiazepines or other anxiolytic drugs.
• Previously received RO4995819.
• Participated in investigational drug or device study w/in 6 mos of screening or in index depressive episode.
• History of non-response to Electroconvulsive Therapy (ECT), Vagus Nerve Stimulation (VNS),or Repetitive Transcranial Magnetic Stimulation (RTMS).
• Planning to begin/change current regimen of individual psychotherapy including cognitive behavioral therapy during the 6 week treatment period of the study and the first 2 weeks of follow-up.
• Present DSM-IV-TR axis I diagnosis except for anxiety comorbidity
• Past or present psychotic symptoms.
• Mood disorder due to medical condition or substance use/abuse/dependence.
• Established personality disorder
• Alcohol and/or substance abuse/dependence during the last 6 months.
• A significant risk for suicidal behavior

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Charles DeBattista, DMH, MD

  Stanford University Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 27, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2014
• Last Updated: October 4, 2019

Record last verified: 2019-10