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ARTDeCo Study: A Study of RO4995819 in Patients With Major Depressive Disorder And Inadequate Response to Ongoing Antidepressant Treatment

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ClinicalTrials.gov Identifier: NCT01457677
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4995819 as adjunctive therapy in patients with major depressive disorder having inadequate response to ongoing antidepressant treatment. Patients will be randomized to receive once daily doses of 5 mg, 15 or 30 mg of RO4995819 or matching placebo. The anticipated time on study treatment is 6 weeks.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Placebo Drug: RO4995819 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 357 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi Center, Randomized, Double-blind, Placebo Controlled, Parallel-group Study to Investigate the Efficacy and Safety of RO4995819 Versus Placebo, as Adjunctive Therapy in Patients With Major Depressive Disorder Having Inadequate Response to Ongoing Antidepressant Treatment (ARTDeCo)
Study Start Date : December 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
matching placebo to RO4995819 oral once daily for 6 weeks

Experimental: RO4995819 15 mg Drug: RO4995819
15 mg oral once daily for 6 weeks

Experimental: RO4995819 30 mg Drug: RO4995819
30 mg oral once daily for 6 weeks

Experimental: RO4995819 5 mg Drug: RO4995819
5 mg oral once daily for 6 weeks




Primary Outcome Measures :
  1. Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Safety (incidence of a adverse events) [ Time Frame: 6 weeks ]
  2. Proportion of patients exhibiting remission based on the Montgomery Asberg Depression Rating Scale (MADRS) (score of </=10) [ Time Frame: 6 weeks ]
  3. Proportion of patients exhibiting response based on the Montgomery Asberg Depression Rating Scale (MADRS) (reduction in score of >/= 50% of the baseline score) [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 index (BMI) 18.0-35.0 kg/m2 inclusive

Exclusion Criteria:

  • Patient currently receives treatment with a combination of 3 or more antidepressants
  • Significant ongoing use of high doses of barbiturates, benzodiazepines or other anxiolytic drugs
  • Patient previously received RO4995819
  • Patient participated in an investigational drug or device trial within 6 months of screening
  • History of non-response to, or current use of non-pharmacological treatment including Electroconvulsive Therapy (ECT), Vagus Nerve Stimulation (VNS), or Repetitive Transcranial Magnetic Stimulation (RTMS)
  • Past or present psychotic symptoms

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01457677


  Show 92 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01457677     History of Changes
Other Study ID Numbers: BP25712
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs