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Be Part of Research - Trial Details - A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)
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A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)

Completed

Open to: ALL

Age: 18.0 - N/A

Edinburgh London Oxford

Medical Conditions

Schizophrenia

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This multi-center, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 in participants with persistent, predominant negative symptoms of schizophrenia. Participants, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 56 weeks (treatment period 1 of 24 weeks and treatment period 2 of 32 weeks), followed by an optional treatment extension for up to 3 years. After 52 weeks, participants who were originally randomized to an active treatment will be randomly assigned to receive either placebo or continue on the originally assigned study treatment for 4 weeks washout period (Week 52 to Week 56) for the assessment of potential withdrawal effects in a blinded manner using participants staying on active treatment as a control. Participants initially randomized to placebo will remain on placebo. After 56 weeks, participants who were switched to placebo in the washout period will return to their blinded, active treatment arm.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2010 May 2014

Publications

"Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20."; "28433500"; "Bugarski-Kirola D, Blaettler T, Arango C, Fleischhacker WW, Garibaldi G, Wang A, Dixon M, Bressan RA, Nasrallah H, Lawrie S, Napieralski J, Ochi-Lohmann T, Reid C, Marder SR. Bitopertin in Negative Symptoms of Schizophrenia-Results From the Phase III FlashLyte and DayLyte Studies. Biol Psychiatry. 2017 Jul 1;82(1):8-16. doi: 10.1016/j.biopsych.2016.11.014. Epub 2016 Dec 15."; "28117049"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Placebo will be administered orally QD for 56 weeks

Intervention Arm Group : Placebo;

Intervention Type : DRUG
Intervention Description : RO4917838 will be administered orally at 20 or 10 mg QD for 56 weeks.

Intervention Arm Group : RO4917838 10 mg;RO4917838 20 milligrams (mg);

Intervention Type : DRUG
Intervention Description : Participants will continue to receive their stable antipshychotic as standard of care based on their prescription up to Week 56.

Intervention Arm Group : Placebo;RO4917838 10 mg;RO4917838 20 milligrams (mg);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Edinburgh Hospital; Psychiatry
    Edinburgh
    EH10 5HF
  • Institute of Pyschiatry
    London
    SE5-8AF
  • Wareneford Hospital
    Oxford
    OX3 7JX


The study is sponsored by Hoffmann-La Roche



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Read full details for Trial ID: NCT01192867
Last updated 23 June 2017

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