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RO4995819

Phase 2

Major Depressive Disorder | Small molecule | Psychiatry |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment357

FDA Designations

No designations recorded

Clinical trial landscape

RO4995819 · 5 trials · 2 indications

Phase 2 1Phase 1 4
NCT01457677ARTDeCo Study: A Study of RO4995819 in Patients With Major Depressive Disorder And Inadequate Response to Ongoing Antidepressant TreatmentMajor Depressive Disorder
COMPLETED357 Analytics
PHASE2COMPLETED
ARTDeCo Study: A Study of RO4995819 in Patients With Major Depressive Disorder And Inadequate Response to Ongoing Antidepressant Treatment
Major Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores
6 weeks
Bioavailability: Plasma concentration of RO4995819
Approximately 3 months
C max: maximum observed plasma concentration
18 weeks
T max: time of maximum observed plasma concentration
18 weeks
T1/2: apparent terminal half-life
18 weeks
AUC: area under the plasma concentration-time curve
18 weeks
Safety (incidence of adverse events)
8 weeks
Safety: Incidence of adverse events
up to 58 days

Secondary Endpoints

Safety (incidence of a adverse events)
6 weeks
Proportion of patients exhibiting remission based on the Montgomery Asberg Depression Rating Scale (MADRS) (score of </=10)
6 weeks
Proportion of patients exhibiting response based on the Montgomery Asberg Depression Rating Scale (MADRS) (reduction in score of >/= 50% of the baseline score)
6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
RO4995819 15 mgEXPERIMENTAL -
RO4995819 30 mgEXPERIMENTAL -
RO4995819 5 mgEXPERIMENTAL -
RO4995819 capsuleEXPERIMENTAL -
RO4995819 tabletEXPERIMENTAL -
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
RO4995819EXPERIMENTAL -

Interventions

NameTypeDescription
PlaceboDRUGmatching placebo to RO4995819 oral once daily for 6 weeks
RO4995819DRUG5 mg oral once daily for 6 weeks
activated charcoalDRUGorally 3 times daily, Days 1-7
citalopramDRUGmultiple oral doses, Days 1-16
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites92

Inclusion Criteria: * Adult patients, 18-65 years of age * Major depression disorder without psychotic features * Inadequate response to current, ongoing antidepressant treatment as defined by protocol * Having at least one but no more than 2 antidepressant treatment trial failures * Body mass inde...

Countries:United StatesAustriaCanadaGermanyRussiaSlovakiaSouth AfricaUkraineFrance
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Frequently asked questions about RO4995819

What is RO4995819 used for?

RO4995819 is an investigational small molecule being studied for Major Depressive Disorder and in healthy volunteer trials. It is developed by Roche Holding AG (ticker: RHHBY). The drug is currently in Phase 1 clinical development, with all four completed trials conducted in healthy volunteers.

Who makes RO4995819?

RO4995819 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored four Phase 1 clinical trials of the drug, all of which have been completed. The trials were conducted in France and the United States.

What phase is RO4995819 in?

RO4995819 is in Phase 1 clinical development. All four of its clinical trials are Phase 1 studies and have been completed. The drug is investigational and has not been approved by regulatory authorities. It is being studied for Major Depressive Disorder and in healthy volunteer trials.

What clinical trials is RO4995819 in?

RO4995819 has been studied in four completed Phase 1 trials: NCT01367756 (combination with citalopram in healthy volunteers), NCT01409369 (effect of activated charcoal on pharmacokinetics), NCT01457664 (healthy elderly volunteers), and NCT01901159 (bioavailability and safety). All trials enrolled healthy volunteers.

Is RO4995819 the same as another drug?

RO4995819 is the sole name provided for this investigational drug. No alternative names have been identified in the available information. The drug is being developed by Roche Holding AG and is in Phase 1 clinical trials for Major Depressive Disorder and healthy volunteer studies.