Major Depressive DisorderPhase 2NCT01457677

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

A Phase 2 study testing RO4995819 in people with Major Depressive Disorder, run by Hoffmann-La Roche at 92 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: RO4995819
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 357 participants
Where: 92 sitesin 8 countries
Study dates: Dec 2011to Jun 2014
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

92 sites in 8 countries.

Country

City, postcode or hospital

92 sites in 8 countries

United States43 sites

Study site
Albuquerque, New Mexico, 87131
Study site
Arlington, Texas, 76012
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Atlanta, Georgia, 30308
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Baltimore, Maryland, 21208
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Beachwood, Ohio, 44122
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Boston, Massachusetts, 02114
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Canton, Ohio, 44718
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Chicago, Illinois, 60612-3244
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Cincinnati, Ohio, 45215
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Cincinnati, Ohio, 45227
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Columbia, South Carolina, 29201
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Coral Springs, Florida, 33067
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Denver, Colorado, 80239
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Durham, North Carolina, 27710
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Flowood, Mississippi, 39232
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Gainsville, Florida, 32607
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Houston, Texas, 77030
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Jacksonville, Florida, 32216
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Jenkintown, Pennsylvania, 19046
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Lauderhill, Florida, 33319
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Media, Pennsylvania, 19063
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New York, New York, 10021
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New York, New York, 10029
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New York, New York, 10032
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North Miami, Florida, 33161
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O'Fallon, Missouri, 63368
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Oakland, California, 94607
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Ocala, Florida, 34471
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Phoenix, Arizona, 85381
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Prairie Village, Kansas, 66206
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Redlands, California, 92374
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Richmond, Virginia, 23298
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Roanoke, Virginia, 24014
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Rochester, New York, 14618
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Roswell, Georgia, 30076
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Salt Lake City, Utah, 84106
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San Diego, California, 92103
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Smyrna, Georgia, 30080
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Stanford, California, 94305
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Torrance, California, 90502
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Victorville, California, 92295
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Watertown, Massachusetts, 02472
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Wichita, Kansas, 67214

Other trials in United States

Russia15 sites

Study site
Lipetsk, 399083
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Moscow, 117105
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Moscow, 117995
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Novosibirsk, 630091
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Saint Petersburg, 190121
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Saint Petersburg, 191119
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Saint Petersburg, 192019
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Saint Petersburg, 199004
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Samara, 443016
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Smolensk, 214019
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Talagi, 163530
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Tomsk, 634014
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Yaroslavl, 150003
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Yekaterinburg, 620030
Study site
Yekaterinburg, 620036

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Ukraine8 sites

Study site
Dnipropetrovsk, 49005
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Donetsk, 83008
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Kharkiv, 61068
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Kherson,Vil. Stepanivka, 73488
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Kiev, 02660
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Odesa, 65006
Study site
Simferopol, Crimea, 95006
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Vinnytsia, 21005

Other trials in Ukraine

Germany7 sites

Study site
Ellwangen, 73479
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Leipzig, 04275
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Mannheim, 68159
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Nuremberg, 90402
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Oranienburg, 16515
Study site
Ostfildern, 73760
Study site
Schwerin, Mecklenburg-Vorpommern, 19053

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Canada6 sites

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Gatineau, Quebec, J9A 1k7
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Kentville, Nova Scotia, B4N 4K9
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Kingston, Ontario, K7L 4X3
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Ottowa, Ontario, K1Z 7K4
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Sherbrooke, Quebec, J1H 4J6
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Verdun, Quebec, H4H 1R3

Other trials in Canada

Slovakia5 sites

Study site
Bratislava, 811 07
Study site
Bratislava, 813 69
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Bratislava, 851 01
Study site
Rimavská Sobota, 979 01
Study site
Trenčín, 911 01

Other trials in Slovakia

South Africa5 sites

Study site
Bellville, Cape Town, 7530
Study site
Cape Town, Western Cape, 7130
Study site
Cape Town, Western CAPE, 7925
Study site
Centurion, Pretoria, 0046
Study site
Nieu Muckleneuk, Pretoria, 0181

Other trials in South Africa

Austria3 sites

Study site
Innsbruck, 6020
Study site
Vienna, 1090
Study site
Wien, Vienna, 1090

Other trials in Austria

About this study

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)

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.

Conditions: Major Depressive Disorder
Being tested: Placebo, RO4995819
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
matching placebo to RO4995819 oral once daily for 6 weeks
RO4995819Drug
5 mg oral once daily for 6 weeks
RO4995819Drug
15 mg oral once daily for 6 weeks
RO4995819Drug
30 mg oral once daily for 6 weeks

Study groups in NCT01457677
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
RO4995819 15 mg	Experimental	Not described Receives: Drug: RO4995819
RO4995819 30 mg	Experimental	Not described Receives: Drug: RO4995819
RO4995819 5 mg	Experimental	Not described Receives: Drug: RO4995819

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores
Measured: 6 weeks

Secondary outcomes (3)

Safety (incidence of a adverse events)
Measured: 6 weeks
Proportion of patients exhibiting remission based on the Montgomery Asberg Depression Rating Scale (MADRS) (score of </=10)
Measured: 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)
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Jun 2014

First posted24 Oct 2011 (estimated)
Study startDec 2011
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 357 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01457677
Sponsor's protocol ID: BP25712
Status last verified: Nov 2016
First submitted: 20 Oct 2011
Last updated: 2 Nov 2016
Results posted: No

Publications

Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.
PubMed 34510411
Umbricht D, Niggli M, Sanwald-Ducray P, Deptula D, Moore R, Grunbauer W, Boak L, Fontoura P. Randomized, Double-Blind, Placebo-Controlled Trial of the mGlu2/3 Negative Allosteric Modulator Decoglurant in Partially Refractory Major Depressive Disorder. J Clin Psychiatry. 2020 Jul 14;81(4):18m12470. doi: 10.4088/JCP.18m12470.
PubMed 32663909

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01457677
Acronym / sponsor ID: BP25712
Conditions: Major Depressive Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 357 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 24 Oct 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
RO4995819 15 mg	Experimental	Drug: RO4995819
RO4995819 30 mg	Experimental	Drug: RO4995819
RO4995819 5 mg	Experimental	Drug: RO4995819

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebomatching placebo to RO4995819 oral once daily for 6 weeks	Drug	Placebo
RO49958195 mg oral once daily for 6 weeks	Drug	RO4995819 5 mg
RO499581915 mg oral once daily for 6 weeks	Drug	RO4995819 15 mg
RO499581930 mg oral once daily for 6 weeks	Drug	RO4995819 30 mg

Primary outcome

Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores
Time frame: 6 weeks

3 secondary outcomes

Safety (incidence of a adverse events)
Time frame: 6 weeks
Proportion of patients exhibiting remission based on the Montgomery Asberg Depression Rating Scale (MADRS) (score of </=10)
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
Derived from this study: PubMed 34510411Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.
Derived from this study: PubMed 32663909Umbricht D, Niggli M, Sanwald-Ducray P, Deptula D, Moore R, Grunbauer W, Boak L, Fontoura P. Randomized, Double-Blind, Placebo-Controlled Trial of the mGlu2/3 Negative Allosteric Modulator Decoglurant in Partially Refractory Major Depressive Disorder. J Clin Psychiatry. 2020 Jul 14;81(4):18m12470. doi: 10.4088/JCP.18m12470.

Related trials for Major Depressive Disorder

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

92 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RO4995819 in people with Major Depressive Disorder, run by Hoffmann-La Roche at 92 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, Russia, Ukraine, Germany, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01457677, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.