Major Depressive DisorderPhase 2NCT01437657
MARIGOLD Study: A Study of RO4917523 Versus Placebo as Adjunctive Therapy in Patients With Major Depressive Disorder and an Inadequate Response to Ongoing Antidepressant Therapy
A Phase 2 study testing RO4917523 0.5 mg and RO4917523 1.5 mg in people with Major Depressive Disorder, run by Hoffmann-La Roche at 76 sites in 9 countries.
Trial summary
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety and efficacy of RO4917523 as adjunctive therapy in patients with major depressive disorder and an inadequate response to ongoing antidepressant therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- RO4917523 0.5 mg and RO4917523 1.5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 319 participants
- Where
- 76 sitesin 9 countries
- Study dates
- Oct 2011to Sep 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient, 18 to 70 years of age at time of informed consent
- Major depressive disorder without psychotic features as defined by DSM-IV-TR criteria
- Inadequate response to ongoing antidepressant treatment, as defined by protocol
- Body mass index (BMI) 18 to 38 kg/m2 inclusive
Who cannot join
- Currently receiving treatment with a combination of antidepressants (two or more), or an adjunctive potentiating treatment as defined by protocol
- Previously received RO4917523
- History of failure, or utilization during the current episode of Electroconvulsive Therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS)
- History of use at any time of Vagus Nerve Stimulation (VNS) or Deep Brain Stimulation (DBS)
- Current or past history of bipolar disorder (e.g. manic, hypomanic, or mixed episodes)
- Pregnant or lactating women
Trial locations and contacts
76 sites in 9 countries.
76 sites in 9 countries
United States28 sites
Study site
Atlanta, Georgia, 30328
Study site
Baltimore, Maryland, 21285
Study site
Brooklyn, New York, 11201
Study site
Cedarhurst, New York, 11516
Study site
Costa Mesa, California, 92626
Study site
Garden Grove, California, 92845
Study site
Kirkland, Washington, 98033
Study site
Las Vegas, Nevada, 89102
Study site
Libertyville, Illinois, 60048
Study site
Little Rock, Arkansas, 72223
Study site
Marlton, New Jersey, 08053
Study site
Memphis, Tennessee, 38119
Study site
Naperville, Illinois, 60563
Study site
Norristown, Pennsylvania, 19403
Study site
Oak Brook, Illinois, 60523
Study site
Oceanside, California, 92056
Study site
Oklahoma City, Oklahoma, 73112
Study site
Orange, California, 92868
Study site
Philadelphia, Pennsylvania, 19104
Study site
Philadelphia, Pennsylvania, 19139
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Riverside, California, 92506
Study site
San Diego, California, 92102
Study site
San Diego, California, 92103
Study site
San Diego, California, 92121
Study site
Santa Ana, California, 92705
Study site
Shreveport, Louisiana, 71115
Study site
Wildomar, California, 92595
Japan18 sites
Study site
Chūōku, 260-8670
Study site
Hokkaido, 060-8648
Study site
Hyōgo, 659-0093
Study site
Kanagawa, 216-8511
Study site
Kanagawa, 252-0303
Study site
Kita-ku, 114-0024
Study site
Kurayoshi-shi, 682-0023
Study site
Kyoto, 618-8421
Study site
Osaka, 569-1041
Study site
Shinjuku-ku, 160-8582
Study site
Tokyo, 100-0006
Study site
Tokyo, 107-0052
Study site
Tokyo, 151-0053
Study site
Tokyo, 157-8577
Study site
Tokyo, 162-0821
Study site
Tokyo, 162-8666
Study site
Tokyo, 170-0002
Study site
Tokyo, 187-8551
Poland7 sites
Study site
Bełchatów, 97-400
Study site
Bialystok, 15-464
Study site
Bialystok, 15-879
Study site
Choroszcz, 16-070
Study site
Kielce, 25-411
Study site
Lodz, 91-229
Study site
Tuszyn, 95-080
Germany6 sites
Study site
Berlin, 10117
Study site
Berlin, 12203
Study site
Freiburg im Breisgau, 79104
Study site
Hanover, 30159
Study site
Mainz, 55131
Study site
Wiesbaden, 65185
Romania6 sites
Study site
Bucharest, 030442
Study site
Bucharest, 031723
Study site
Constanța, 900002
Study site
Craiova, 200620
Study site
Targouiste, 130086
Study site
Târgu Mureş, 540139
Chile3 sites
Study site
Santiago, 7500710
Study site
Santiago, 7580307
Study site
Temuco, 4781151
Mexico3 sites
Study site
Aguascalientes, 20127
Study site
León, 37000
Study site
Monterrey, 64060
Taiwan3 sites
Study site
Keelung, 20445
Study site
Taichung, 40447
Study site
Taipei, 00112
Russia2 sites
Study site
Saint Petersburg, 190121
Study site
Saint Petersburg, 192019
About this study
Official title: A Randomized, Double-blind, Parallel-group Study of the Safety and Efficacy of RO4917523 Versus Placebo, as Adjunctive Therapy in Patients With Major Depressive Disorder With Inadequate Response to Ongoing Antidepressant Treatment
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety and efficacy of RO4917523 as adjunctive therapy in patients with major depressive disorder and an inadequate response to ongoing antidepressant therapy. Anticipated time on study treatment is 6 weeks with a 3-week follow-up.
- Conditions
- Major Depressive Disorder
- Being tested
- Placebo, RO4917523 0.5 mg, RO4917523 1.5 mg
- 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 RO4917523 placebo orally daily, 6 weeks
RO4917523 0.5 mgDrug
0.5 mg orally daily, 6 weeks
RO4917523 1.5 mgDrug
1.5 mg orally daily, 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching RO4917523 placebo orally daily, 6 weeks Receives: Drug: Placebo |
| RO4917523 0.5 mg | Experimental | 0.5 mg orally daily, 6 weeks Receives: Drug: RO4917523 0.5 mg |
| RO4917523 1.5 mg | Experimental | 1.5 mg orally daily, 6 weeks Receives: Drug: RO4917523 1.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery Asberg Depression Rating Scale (MADRS)
Measured: From baseline to Week 6
Secondary outcomes (5)
Change in Clinical Global Impression Score - Severity (CGI-S)
Measured: From baseline to Week 6
Change in Clinical Global Impression Score - Improvement (CGI-I)
Measured: From baseline to Week 6
Safety: Incidence of adverse events
Measured: approximately 2 years
Proportion of patients exhibiting remission (MADRS </= 10) after 6 weeks of treatment
Measured: approximately 2 years
Proportion of patients exhibiting response (reduction in MADRS >/= 50% of baseline score) after 6 weeks of treatment
Measured: approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437657
- Sponsor's protocol ID
- NP25620
- Other IDs
- 2011-001436-33
- Status last verified
- Nov 2016
- First submitted
- 20 Sep 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Quiroz JA, Tamburri P, Deptula D, Banken L, Beyer U, Rabbia M, Parkar N, Fontoura P, Santarelli L. Efficacy and Safety of Basimglurant as Adjunctive Therapy for Major Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jul 1;73(7):675-84. doi: 10.1001/jamapsychiatry.2016.0838.
PubMed 27304433
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 Randomized, Double-blind, Parallel-group Study of the Safety and Efficacy of RO4917523 Versus Placebo, as Adjunctive Therapy in Patients With Major Depressive Disorder With Inadequate Response to Ongoing Antidepressant Treatment
- ClinicalTrials.gov ID
- NCT01437657
- Acronym / sponsor ID
- NP25620
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 21 Sep 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.
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety and efficacy of RO4917523 as adjunctive therapy in patients with major depressive disorder and an inadequate response to ongoing antidepressant therapy. Anticipated time on study treatment is 6 weeks with a 3-week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboMatching RO4917523 placebo orally daily, 6 weeks |
| RO4917523 0.5 mg | Experimental | Drug: RO4917523 0.5 mg0.5 mg orally daily, 6 weeks |
| RO4917523 1.5 mg | Experimental | Drug: RO4917523 1.5 mg1.5 mg orally daily, 6 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient, 18 to 70 years of age at time of informed consent
- Major depressive disorder without psychotic features as defined by DSM-IV-TR criteria
- Inadequate response to ongoing antidepressant treatment, as defined by protocol
- Body mass index (BMI) 18 to 38 kg/m2 inclusive
Key exclusion criteria (6 listed)
- Currently receiving treatment with a combination of antidepressants (two or more), or an adjunctive potentiating treatment as defined by protocol
- Previously received RO4917523
- History of failure, or utilization during the current episode of Electroconvulsive Therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS)
- History of use at any time of Vagus Nerve Stimulation (VNS) or Deep Brain Stimulation (DBS)
- Current or past history of bipolar disorder (e.g. manic, hypomanic, or mixed episodes)
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 RO4917523 placebo orally daily, 6 weeks | Drug | Placebo |
| RO4917523 0.5 mg0.5 mg orally daily, 6 weeks | Drug | RO4917523 0.5 mg |
| RO4917523 1.5 mg1.5 mg orally daily, 6 weeks | Drug | RO4917523 1.5 mg |
Primary outcome
Change in Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: From baseline to Week 6
5 secondary outcomes
Change in Clinical Global Impression Score - Severity (CGI-S)
Time frame: From baseline to Week 6
Change in Clinical Global Impression Score - Improvement (CGI-I)
Time frame: From baseline to Week 6
Safety: Incidence of adverse events
Time frame: approximately 2 years
Proportion of patients exhibiting remission (MADRS </= 10) after 6 weeks of treatment
Time frame: approximately 2 years
Proportion of patients exhibiting response (reduction in MADRS >/= 50% of baseline score) after 6 weeks of treatment
Time frame: approximately 2 years
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 27304433Quiroz JA, Tamburri P, Deptula D, Banken L, Beyer U, Rabbia M, Parkar N, Fontoura P, Santarelli L. Efficacy and Safety of Basimglurant as Adjunctive Therapy for Major Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jul 1;73(7):675-84. doi: 10.1001/jamapsychiatry.2016.0838.
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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
76 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RO4917523 0.5 mg and RO4917523 1.5 mg in people with Major Depressive Disorder, run by Hoffmann-La Roche at 76 sites in 9 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 4 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 76 sites in United States, Japan, Poland, Germany, Romania and 4 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?
Change in Montgomery Asberg Depression Rating Scale (MADRS) (time frame: From baseline to Week 6). 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 NCT01437657, which also lists 1 linked publication.
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.