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

November 1, 2016 updated by: Hoffmann-La Roche

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
357

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
      • Wien, Austria, 1090
      • Wien, Vienna, Austria, 1090
  • Canada
    • Nova Scotia
      • Kentville,, Nova Scotia, Canada, B4N 4K9
    • Ontario
      • Kingston, Ontario, Canada, K7L 4X3
      • Ottowa, Ontario, Canada, K1Z 7K4
    • Quebec
      • Gatineau, Quebec, Canada, J9A 1k7
      • Sherbrooke, Quebec, Canada, J1H 4J6
      • Verdun, Quebec, Canada, H4H 1R3
  • Germany
      • Ellwangen, Germany, 73479
      • Leipzig, Germany, 04275
      • Mannheim, Germany, 68159
      • Nürnberg, Germany, 90402
      • Oranienburg, Germany, 16515
      • Ostfildern, Germany, 73760
      • Schwerin, Mecklenburg-Vorpommern, Germany, 19053
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620036
      • Ekaterinburg, Russian Federation, 620030
      • Lipetsk, Russian Federation, 399083
      • Moscow, Russian Federation, 117995
      • Moscow, Russian Federation, 117105
      • Novosibirsk, Russian Federation, 630091
      • Saint Petersburg, Russian Federation, 191119
      • Samara, Russian Federation, 443016
      • Smolensk, Russian Federation, 214019
      • St Petersburg, Russian Federation, 192019
      • St. Petersburg, Russian Federation, 190121
      • St. Petersburg, Russian Federation, 199004
      • Talagi, Russian Federation, 163530
      • Tomsk, Russian Federation, 634014
      • Yaroslavl, Russian Federation, 150003
  • Slovakia
      • Bratislava, Slovakia, 851 01
      • Bratislava, Slovakia, 811 07
      • Bratislava, Slovakia, 813 69
      • Rimavska Sobota, Slovakia, 979 01
      • Trencin, Slovakia, 911 01
  • South Africa
      • Bellville, Cape Town, South Africa, 7530
      • Cape Town, WESTERN CAPE, South Africa, 7925
      • Cape Town, Western Cape, South Africa, 7130
      • Centurion, Pretoria, South Africa, 0046
      • Nieu Muckleneuk, Pretoria, South Africa, 0181
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49005
      • Donetsk, Ukraine, 83008
      • Kharkiv, Ukraine, 61068
      • Kherson,Vil. Stepanivka, Ukraine, 73488
      • Kiev, Ukraine, 02660
      • Odessa, Ukraine, 65006
      • Simferopol, Crimea, Ukraine, 95006
      • Vinnytsya, Ukraine, 21005
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85381
    • California
      • Oakland, California, United States, 94607
      • Redlands, California, United States, 92374
      • San Diego, California, United States, 92103
      • Stanford, California, United States, 94305
      • Torrance, California, United States, 90502
      • Victorville, California, United States, 92295
    • Colorado
      • Denver, Colorado, United States, 80239
    • Florida
      • Coral Springs, Florida, United States, 33067
      • Gainsville, Florida, United States, 32607
      • Jacksonville, Florida, United States, 32216
      • Lauderhill, Florida, United States, 33319
      • North Miami, Florida, United States, 33161
      • Ocala, Florida, United States, 34471
    • Georgia
      • Atlanta, Georgia, United States, 30308
      • Roswell, Georgia, United States, 30076
      • Smyrna, Georgia, United States, 30080
    • Illinois
      • Chicago, Illinois, United States, 60612-3244
    • Kansas
      • Prairie Village, Kansas, United States, 66206
      • Wichita, Kansas, United States, 67214
    • Maryland
      • Baltimore, Maryland, United States, 21208
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Watertown, Massachusetts, United States, 02472
    • Mississippi
      • Flowood, Mississippi, United States, 39232
    • Missouri
      • O'Fallon, Missouri, United States, 63368
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • New York
      • New York, New York, United States, 10032
      • New York, New York, United States, 10021
      • New York, New York, United States, 10029
      • Rochester, New York, United States, 14618
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Beachwood, Ohio, United States, 44122
      • Canton, Ohio, United States, 44718
      • Cincinnati, Ohio, United States, 45227
      • Cincinnati, Ohio, United States, 45215
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
      • Media, Pennsylvania, United States, 19063
    • South Carolina
      • Columbia, South Carolina, United States, 29201
    • Texas
      • Arlington, Texas, United States, 76012
      • Houston, Texas, United States, 77030
    • Utah
      • Salt Lake City, Utah, United States, 84106
    • Virginia
      • Richmond, Virginia, United States, 23298
      • Roanoke, Virginia, United States, 24014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
matching placebo to RO4995819 oral once daily for 6 weeks
Experimental: RO4995819 15 mg
Drug: RO4995819
5 mg oral once daily for 6 weeks
Drug: RO4995819
15 mg oral once daily for 6 weeks
Drug: RO4995819
30 mg oral once daily for 6 weeks
Experimental: RO4995819 30 mg
Drug: RO4995819
5 mg oral once daily for 6 weeks
Drug: RO4995819
15 mg oral once daily for 6 weeks
Drug: RO4995819
30 mg oral once daily for 6 weeks
Experimental: RO4995819 5 mg
Drug: RO4995819
5 mg oral once daily for 6 weeks
Drug: RO4995819
15 mg oral once daily for 6 weeks
Drug: RO4995819
30 mg oral once daily for 6 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Safety (incidence of a adverse events)
Time Frame: 6 weeks
6 weeks
Proportion of patients exhibiting remission based on the Montgomery Asberg Depression Rating Scale (MADRS) (score of </=10)
Time Frame: 6 weeks
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)
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BP25712

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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