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Completed

NCT Number: NCT01457677

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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

matching placebo to RO4995819 oral once daily for 6 weeks

RO4995819

Drug

5 mg oral once daily for 6 weeks

Primary outcomes

  1. Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores

    Time frame: 6 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 24, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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