Sodium benzoate in chronic schizophrenia – an open label, add-on safety and efficacy study

Phase 1

• Conditions: Schizophrenia; Treatment Resistance; Mental Health - Schizophrenia

• Registration Number: ACTRN12615000460505
• Lead Sponsor: niveristy of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-12
• Study Completion: 2016-06-01
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1.A clinical diagnosis of Schizophrenia, confirmed by a structured diagnostic interview.
2.Have a body mass index between 18 and 35 (that is, not underweight or markedly overweight)
3.Have had no major change in their symptoms for three months.
4.Have moderate to severe current symptom

Exclusion Criteria

1.You are pregnant or are intending to become pregnant.
2.Have a history of alcohol or drug dependance.
3.Have a history of epilepsy, head injury, or a neurological disorder.
4.If participating in the trial would place you at unacceptable risk.
5.If you are considered highly likely to not take any medications, as part of the study or not.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive and Negative Symptom Scale (PANSS)[12 week end point];Scales for the Assessment of Negative Symptoms -- 20 item scale (SANS)[12 weeks];Clinical Global Improvement (CGI)[12 weeks]

Secondary Outcome Measures

Name	Time	Method
MATRICS Consensus Cognitive Battery (MCCB)[12 weeks];Beck Hopelessness Scale[12 weeks];Reward Behaviour: Stimulus Chase Task (SCT) and Effort Expenditure for Rewards Task<br>(EEfRT)[12 weeks];Rosenberg Self-esteem Scale[12 weeks];Functional MRI prediction outcome[Prior treatment and end of treatment]