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

This study is currently recruiting participants.
Verified November 2012 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01733654
First received: November 20, 2012
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Depression
Major Depressive Disorder
 Biological: RO4995819
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center Randomized Double-blind Placebo-controlled Parallel-group Study to Investigate Efficacy and Safety of RO4995819 vs Placebo, as Adjunct Therapy in Patients w/Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RO4995819 5mg
RO4995819 5mgX6wks
 Biological: RO4995819
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.
Other Names:
  • RO4995819, 5mg
  • RO4995819, 15mg
  • RO4995819, 30mg
  • Placebo, (a pill that does not contain active drug)
Active Comparator: RO4995819 15mg
RO4995819 15mg X 6 weeks
 Biological: RO4995819
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.
Other Names:
  • RO4995819, 5mg
  • RO4995819, 15mg
  • RO4995819, 30mg
  • Placebo, (a pill that does not contain active drug)
Active Comparator: RO4995819 30mg
RO4995819 30mg X 6 weeks
 Biological: RO4995819
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.
Other Names:
  • RO4995819, 5mg
  • RO4995819, 15mg
  • RO4995819, 30mg
  • Placebo, (a pill that does not contain active drug)
Placebo Comparator: Placebo
Placebo X 6 weeks
 Biological: RO4995819
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.
Other Names:
  • RO4995819, 5mg
  • RO4995819, 15mg
  • RO4995819, 30mg
  • Placebo, (a pill that does not contain active drug)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients are eligible for enrollment in this study if they meet all of the following criteria:

  1. An outpatient w/a primary diagnosis of major depressive disorder w/out psychotic features
  2. Inadequate response to current, ongoing antidepressant tx of SSRI/SNRI.
  3. Having at least 1 but no more than 2 antidepressant treatment failures w/in the index depressive episode

  4. Dose/duration of antidepressant treatment in index episode can be verified by documentation from one of following:

    1. Med records;
    2. Pharmacy records;
    3. Treating and/or referring physician (indicating medication, dose, dates of treatment).
  5. Documentation of clinical/treatment history must be available.
  6. Index depressive episode started w/in 1 year of screening.
  7. Confirmed compliance w/current SSRI/SNRI treatment based on blood screen.
  8. Existing med regimens should be stable for 6 wks prior to screening
  9. 18-65 y.o. at time of consent
  10. BMI 18.0 to 35.0 kg/m2 inc.

  11. 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:

    • Males w/partners of childbearing potential or partners must use a barrier method of contraception or remain sexually abstinent.
    • Females who are not either surgically sterile (tubal ligation, removal of ovaries or uterus) or post-menopausal (no spontaneous menstrual periods for at least 1 yr confirmed by a hormone panel [FSH and 17βestradiol])must agree to use 2 adequate methods of contraception, including at least one method w/ failure rate of < 1% per yr (e.g., hormonal implants, combined oral contraceptives, vasectomized partner, abstinence).
  12. Able to participate and willing to give written informed consent.

Exclusion Criteria:

Patients are excluded from this study if the answer is 'yes' to any of the following:

Current and past treatment history:

  1. Currently receiving tx w/3 or more antidepressants.
  2. Currently receiving tx w/prohibited meds.
  3. Significant ongoing use of high doses of barbiturates, benzodiazepines or other anxiolytic drugs.
  4. Previously received RO4995819.
  5. Participated in investigational drug or device study w/in 6 mos of screening or in index depressive episode.
  6. History of non-response to Electroconvulsive Therapy (ECT), Vagus Nerve Stimulation (VNS),or Repetitive Transcranial Magnetic Stimulation (RTMS).
  7. 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.
  8. Present DSM-IV-TR axis I diagnosis except for anxiety comorbidity
  9. Past or present psychotic symptoms.
  10. Mood disorder due to medical condition or substance use/abuse/dependence.
  11. Established personality disorder
  12. Alcohol and/or substance abuse/dependence during the last 6 months.
  13. A significant risk for suicidal behavior
  14. Past or present neurological disorder.
  15. Present eating disorder
  16. Abnormal thyroid function.
  17. Active upper gastrointestinal tract disease
  18. Unstable medical condition that could pose unacceptable risk to the patient in this study.
  19. Positive result on hepatitis B (HBV), hepatitis C (HCV), or HIV 1 and 2.
  20. Positive test for drugs of abuse.
  21. Abnormality on 12-lead electrocardiogram (ECG), including a QTcF of ≥450 milliseconds.
  22. Lab abnormality
  23. Positive pregnancy test, breast feeding,or intention to become pregnant during the course of the trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733654

Contacts
Contact: Maureen Chang, B.S. 650-725-4620 mhchang@stanford.edu
Contact: Jessica Hawkins, B.A. 650-723-8323 jhawk@stanford.edu

Locations
United States, California
Stanford University Department of Psychiatry Recruiting
Stanford, California, United States, 94305-5723
Principal Investigator: Charles DeBattista, DMH, MD            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Charles DeBattista, DMH, MD Stanford University Department of Psychiatry
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01733654     History of Changes
Other Study ID Numbers: 23708
Study First Received: November 20, 2012
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
depression
major depressive disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013