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Completed

NCT Number: NCT01516424

Efficiency Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone

A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Anding Hospital, Beijing, Beijing Municipality, China

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About this study

A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone

Trial drugs:

  • Blonanserin group: Blonanserin tablets+Risperidone mimetic tablets
  • Risperidone group: Risperidone tablets+Blonanserin mimetic tablets

Objectives of Study :

To evaluate the efficacy and safety of Blonanserin in treating schizophrenia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject met Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV-Text Revision(TR) criteria for a primary diagnosis of schizophrenia
  • Patients are 18≤age<65 years of age on the day when informed consent is obtained.
  • Subject had a PANSS total score ≥70 and 120≥ at Screening
  • Subject had a score ≥4 on the PANSS at Screening and Baseline.
  • Subjects are willing and able to comply with study protocol including treatment in hospital.
  • Subjects or their legal guardians have signed the written informed consent form.

Exclusion criteria

  • The subject was treatment with other Investigate product within 30 days.
  • Subject had a history of treatment with long-acting drug for anti schizophrenia within 56 days.
  • Subject had a history of treatment with clozapine within 28 days.
  • Subject With parkinson disease,etc

Treatment and study plan

Blonanserin

Drug

Blonanserin tablets: 8 - 24mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days.

Other names: Lonasen

Risperidone

Drug

Risperidone tablets: 2 - 6mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days.

Other names: Risperdal

Primary outcomes

  1. Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8

    Time frame: From baseline to the end of study、week 8(day 56)or before other antipsychotic taken.

    Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 8 at the end of treatment. PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. It have 30 evaluation items, which include 7 positive sub-scale, 7 negative sub-scale and 16 general psychopathology sub-scale on a score of 1 to 7. The total score is the sum of the 30 scale items. The minimum score is 30 and the maximum score is 210. Patient with PANSS total scores<70 is the normal,but the scores>120 is more serious.Change=(Week 8 Score - Baseline score)

Secondary outcomes

  1. Mean Change in PANSS Subscale Score at the End of Treatment

    Time frame: week 8

    Mean Change in PANSS subscale score at the end of treatment at 8 weeks the frame of 8 weeks is from baseline

  2. Mean Change in PANSS 5-factor Model

    Time frame: Week 8

    Mean change in PANSS 5-factor model from baseline at Week 8

  3. Mean Change in PANSS Symptom Scores

    Time frame: Week 8

    Mean change in PANSS symptom scores from baseline at Week 8

  4. Mean Change in PANSS Symptom Scores From Baseline at Each Visit

    Time frame: Each Visit

    Mean change in PANSS symptom scores from baseline at each Visit from baseline at week 8

Sponsors and collaborators

Lead sponsor

Marubeni Pharmaceuticals (Suzhou) Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 24, 2012
Registry last updated
Nov 27, 2018

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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