- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01733654
Investigate Efficacy & Safety of RO4995819 vs. Placebo as Adjunct Tx in Patients w/Major Depressive Disorder
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
- 18-65 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:
- 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).
- 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:
- 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
- Past or present neurological disorder.
- Present eating disorder
- Abnormal thyroid function.
- Active upper gastrointestinal tract disease
- Unstable medical condition that could pose unacceptable risk to the patient in this study.
- Positive result on hepatitis B (HBV), hepatitis C (HCV), or HIV 1 and 2.
- Positive test for drugs of abuse.
- Abnormality on 12-lead electrocardiogram (ECG), including a QTcF of ≥450 milliseconds.
- Lab abnormality
- Positive pregnancy test, breast feeding,or intention to become pregnant during the course of the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: RO4995819 5mg
RO4995819 5mgX6wks
|
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:
|
Active Comparator: RO4995819 15mg
RO4995819 15mg X 6 weeks
|
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:
|
Active Comparator: RO4995819 30mg
RO4995819 30mg X 6 weeks
|
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:
|
Placebo Comparator: Placebo
Placebo X 6 weeks
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Montgomery Asberg Depression Rating Scale
Time Frame: 6 weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Charles DeBattista, DMH, MD, Stanford University Department of Psychiatry
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23708
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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