AzTrials
AzTrials

SchizophreniaPhase 2NCT00616798

A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia.

A Phase 2 study testing RO4917838 and Standard antipsychotic therapy in people with Schizophrenia, run by Hoffmann-La Roche at 73 sites in 10 countries.

Completed

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

Official record
Search all trials

Trial summary

This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone, paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Schizophrenia
What is being tested?
RO4917838 and Standard antipsychotic therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
323 participants
Where
73 sitesin 10 countries
Study dates
Mar 2008to Feb 2010
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • adult patients, 18-60 years of age;
  • diagnosis of schizophrenia (based on screening tests);
  • outpatients, with no hospitalization for worsening of schizophrenia within 3 months;
  • medically and psychiatrically stable over prior 1 month and psychiatrically stable without symptom exacerbation within prior 3 months;
  • currently taking no more than 2 antipsychotic drugs.

Who cannot join

  • began a new non-medication treatment for schizophrenia or other psychiatric condition within last 3 months;
  • on >1 antidepressant, or a change in dose of antidepressant within 3 months;
  • alcohol or substance abuse or dependence within 3 months;
  • has previously received RO4917838.

Trial locations and contacts

73 sites in 10 countries.

73 sites in 10 countries

United States14 sites

  • Study site

    Atlanta, Georgia, 30308

  • Study site

    Austin, Texas, 78754

  • Study site

    Austin, Texas, 78756

  • Study site

    Brooklyn, New York, 11203

  • Study site

    Cincinnati, Ohio, 45267

  • Study site

    DeSoto, Texas, 75115

  • Study site

    Granada Hills, California, 91344

  • Study site

    Hoffman Estates, Illinois, 60169

  • Study site

    Irving, Texas, 75062

  • Study site

    Los Angeles, California, 90033

  • Study site

    Oceanside, California, 92056

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Philadelphia, Pennsylvania, 19139

  • Study site

    Torrance, California, 90502

Other trials in United States

Japan13 sites

  • Study site

    Aichi, 470-1192

  • Study site

    Chiba, 272-8516

  • Study site

    Fukuoka, 807-8555

  • Study site

    Fukuoka, 812-8582

  • Study site

    Gunma, 373-0054

  • Study site

    Kanagawa, 232-0024

  • Study site

    Kanagawa, 236-0004

  • Study site

    Nagasaki, 852-8501

  • Study site

    Saga, 842-0192

  • Study site

    Sapporo, 060-8638

  • Study site

    Tokushima, 770-8503

  • Study site

    Tokyo, 162-8666

  • Study site

    Tokyo, 187-8551

Other trials in Japan

Russia10 sites

  • Study site

    Kazan', 420012

  • Study site

    Lipetsk, 399313

  • Study site

    Moscow, 115522

  • Study site

    Moscow, 117152

  • Study site

    Moscow, 123367

  • Study site

    Nizhny Novgorod, 603155

  • Study site

    Saint Petersburg, 190005

  • Study site

    Saint Petersburg, 192019

  • Study site

    Saint Petersburg, 193019

  • Study site

    Saint Petersburg, 193167

Other trials in Russia

Hungary8 sites

  • Study site

    Balassagyarmat, 2660

  • Study site

    Budapest, 1083

  • Study site

    Budapest, 1097

  • Study site

    Budapest, 1125

  • Study site

    Budapest, 1135

  • Study site

    GYR, 9024

  • Study site

    Gyula, 5700

  • Study site

    Nyíregyháza, 4400

Other trials in Hungary

Brazil6 sites

  • Study site

    Curitiba, 80520-000

  • Study site

    Pelotas, 96030-002

  • Study site

    Rio de Janeiro, 21020-130

  • Study site

    Salvador, 40301-500

  • Study site

    São Paulo, 04044-000

  • Study site

    São Paulo, 05403-010

Other trials in Brazil

Germany6 sites

  • Study site

    Achim, 28832

  • Study site

    Bochum, 44805

  • Study site

    Freiburg im Breisgau, 79104

  • Study site

    Hamburg, 20246

  • Study site

    Nuremberg, 90402

  • Study site

    Westerstede, 26655

Other trials in Germany

Poland6 sites

  • Study site

    Bydgoszcz, 85-096

  • Study site

    Kielce, 25-317

  • Study site

    Skorzewo, 60-165

  • Study site

    Torun, 87-100

  • Study site

    Tuszyn, 95-080

  • Study site

    Żuromin, 09-300

Other trials in Poland

Mexico5 sites

  • Study site

    Mexico City, 06100

  • Study site

    Mexico City, 11560

  • Study site

    Mexico City, 1400

  • Study site

    Mexico City, 14370

  • Study site

    Monterrey, 64710

Other trials in Mexico

France3 sites

  • Study site

    Marseille, 13009

  • Study site

    Orvault, 44700

  • Study site

    Toulon, 83056

Other trials in France

Austria2 sites

  • Study site

    Vienna, 1010

  • Study site

    Vienna, 1090

Other trials in Austria

About this study

Official title: Randomized, Double-blind, Placebo-controlled add-on Trial of the Safety and Efficacy of RO4917838 in Outpatients on Select Atypical Antipsychotics With Prominent Negative or Disorganized Thought Symptoms

This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone, paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms. After a 4 week run in period on their current anti psychotic treatment, patients will be randomized to receive placebo 10mg, 30mg, or 60mg of RO4917838 once daily, p.o., as add-on therapy. The anticipated time o n study treatment is <3 months, and the target sample size is 100-500 individual s.

Conditions
Schizophrenia
Being tested
RO4917838, Placebo, Standard antipsychotic therapy
Medical subject headings
Schizophrenia

What participants receive

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

  • RO4917838Drug

    10mg po daily

  • RO4917838Drug

    30mg po daily

  • RO4917838Drug

    60mg po daily

  • PlaceboDrug

    po daily

  • Standard antipsychotic therapyDrug

    As prescribed

Study groups in NCT00616798
Study groupRoleWhat they receive
3ExperimentalNot described
Receives: Drug: RO4917838; Drug: Standard antipsychotic therapy
4Placebo comparatorNot described
Receives: Drug: Placebo; Drug: Standard antipsychotic therapy
1ExperimentalNot described
Receives: Drug: RO4917838; Drug: Standard antipsychotic therapy
2ExperimentalNot described
Receives: Drug: RO4917838; Drug: Standard antipsychotic therapy

What is being measured

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

  1. Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score.

    Measured: Week 8

Secondary outcomes (2)

  1. Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes.

    Measured: Throughout study

  2. AEs, laboratory parameters, C-SSRS

    Measured: Throughout study

Timeline

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

  1. First posted15 Feb 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

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
323 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00616798
Sponsor's protocol ID
NN20372
Status last verified
Jun 2014
First submitted
4 Feb 2008
Last updated
24 Jun 2014
Results posted
No

Publications

  • Umbricht D, Alberati D, Martin-Facklam M, Borroni E, Youssef EA, Ostland M, Wallace TL, Knoflach F, Dorflinger E, Wettstein JG, Bausch A, Garibaldi G, Santarelli L. Effect of bitopertin, a glycine reuptake inhibitor, on negative symptoms of schizophrenia: a randomized, double-blind, proof-of-concept study. JAMA Psychiatry. 2014 Jun;71(6):637-46. doi: 10.1001/jamapsychiatry.2014.163.

    PubMed 24696094

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RO4917838 and Standard antipsychotic therapy in people with Schizophrenia, run by Hoffmann-La Roche at 73 sites in 10 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 4 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 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Japan, Russia, Hungary, Brazil and 5 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 from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score. (time frame: Week 8). 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 NCT00616798, 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 24 Jun 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in