Investigate Efficacy & Safety of RO4995819 vs. Placebo as Adjunct Tx in Patients w/Major Depressive Disorder
Depression, Major Depressive Disorder
About this trial
This is an interventional treatment trial for Depression focused on measuring depression, major depressive disorder
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
RO4995819 5mg
RO4995819 15mg
RO4995819 30mg
Placebo
RO4995819 5mgX6wks
RO4995819 15mg X 6 weeks
RO4995819 30mg X 6 weeks
Placebo X 6 weeks