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Completed

NCT Number: NCT01192867

A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro SERES, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype
  • Predominant negative symptoms
  • With the exception of clozapine, participants are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics)

Exclusion criteria

  • Evidence that participant has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
  • Body Mass Index (BMI) of less than (<) 17 or greater than (>) 40 kilograms per meter square (kg/m^2)
  • Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS)
  • A severity score of 3 or greater on the Parkinsonism item of the Exrapyramidal Symptoms Rating Scale-Abbreviated (ESRS-A) (Clinical Global Impression, Parkinsonism)

Treatment and study plan

Placebo

Drug

Placebo will be administered orally QD for 56 weeks

RO4917838

Drug

RO4917838 will be administered orally at 20 or 10 mg QD for 56 weeks.

Antipshychotics (Standard of Care)

Drug

Participants will continue to receive their stable antipshychotic as standard of care based on their prescription up to Week 56.

Primary outcomes

  1. Change From Baseline in the Positive and Negative Symptoms Scales (PANSS) Negative Symptoms Factor Score at Week 24 (All-Participant Population)

    Time frame: Baseline, Week 24

  2. Percentage of Participants With Adverse Events (All-Participant Population)

    Time frame: Week 24

Secondary outcomes

  1. Change From Baseline in the PANSS Negative Symptoms Factor Score at Week 24 (Complement Factor H Related Protein 1 High [CFHR1-High] Subgroup Population)

    Time frame: Baseline, Week 24

  2. Change From Baseline in the Personal and Social Performance (PSP) Total Score at Week 24 (All-Participant Population)

    Time frame: Baseline, Week 24

  3. Change From Baseline in the PSP Total Score at Week 24 (CFHR1-High Subgroup Population)

    Time frame: Baseline, Week 24

  4. Change From Baseline in the PANSS Total Score at Week 24 (All-Participant Population)

    Time frame: Baseline, Week 24

  5. Change From Baseline in the PANSS Total Score at Week 24 (CFHR1-High Subgroup Population)

    Time frame: Baseline, Week 24

  6. Change From Baseline in the PANSS Factor Score at Week 24 (All-Participant Population)

    Time frame: Baseline, Week 24

  7. Change From Baseline in the PANSS Factor Score at Week 24 (CFHR1-High Subgroup Population)

    Time frame: Baseline, Week 24

  8. Change From Baseline in the PANSS Subscale Scores at Week 24 (All-Participant Population)

    Time frame: Baseline, Week 24

  9. Change From Baseline in the PANSS Subscale Scores at Week 24 (CFHR1-High Subgroup Population)

    Time frame: Baseline, Week 24

  10. Percentage of Participants Who Have at least 20 Percent (%) Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 (All-Participant Population)

    Time frame: Baseline, Week 24

  11. Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 (CFHR1-High Subgroup Population)

    Time frame: Baseline, Week 24

  12. Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score for Two out of Three Assessments During 24 Weeks (All-Participant Population)

    Time frame: Baseline up to Week 24

  13. Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score for Two out of Three Assessments During 24 Weeks (CFHR1-High Subgroup Population)

    Time frame: Baseline up to Week 24

  14. Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on Clinical Global Impression - Improvement (CGI-I) Score (All-Participant Population)

    Time frame: Baseline, Week 24

  15. Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on CGI-I Score (CFHR1 Subgroup Population)

    Time frame: Baseline, Week 24

  16. Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on CGI-I Score for Two out of Three Assessments During 24 Weeks (All-Participant Population)

    Time frame: Baseline up to Week 24

  17. Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on CGI-I Score for Two out of Three Assessments During 24 Weeks (CFHR1 Subgroup Population)

    Time frame: Baseline up to Week 24

  18. Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score (All-Participant Population)

    Time frame: Baseline, Week 24

  19. Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score (CFHR1 Subgroup Population)

    Time frame: Baseline, Week 24

  20. Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score for Two out of Three Assessments During 24 Weeks (All-Participant Population)

    Time frame: Baseline up to Week 24

  21. Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score for Two out of Three Assessments During 24 Weeks (CFHR1 Subgroup Population)

    Time frame: Baseline up to Week 24

  22. Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 and Improvement in the Negative Symptoms Based on CGI-I Negative Symptoms Score (All-Participant Population)

    Time frame: Baseline, Week 24

  23. Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 and Improvement in the Negative Symptoms Based on CGI-I Negative Symptoms Score (CFHR1 Subgroup Population)

    Time frame: Baseline, Week 24

  24. Change From Baseline in Severity of Illness Based on Clinical Global Impression - Severity (CGI-S) Overall Score (All-Participant Population)

    Time frame: Baseline, Week 24

  25. Change From Baseline in Severity of Illness Based on CGI-S Overall Score (CFHR1 Subgroup Population)

    Time frame: Baseline, Week 24

  26. Change From Baseline in Severity of Illness Based on CGI-S Negative Symptoms Score (All-Participant Population)

    Time frame: Baseline, Week 24

  27. Change From Baseline in Severity of Illness Based on CGI-S Negative Symptoms Score (CFHR1 Subgroup Population)

    Time frame: Baseline, Week 24

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase III, Multi-Center, Randomized, 24 Week, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate Efficacy and Safety of RO4917838 in Stable Patients With Persistent, Predominant Negative Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 28 Week, Double-Blind Treatment Period

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 1, 2010
Registry last updated
Jun 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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