Sodium Benzoate and/or N-Acetylcysteine Added to TAU in Patients With Early Schizophrenia Spectrum Disorder.

Study Overview
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Brief Summary
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This study aims to determine if the addition of Sodium Benzoate and / or NAC to TAU will be acceptable and tolerable and result in overall improvement of symptoms, social and cognitive functioning in patients with early schizophrenia spectrum disorder.

Official Title
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A Multicentre 12-week Randomised Double-blind Placebo Controlled Feasibility Trial of Sodium Benzoate and/or N-acetylcysteine Added to TAU in Patients With Early Schizophrenia Spectrum Disorder.

Conditions
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Schizophrenia, Schizophreniform Disorders, Schizoaffective Disorder

Intervention / Treatment
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* Drug: Sodium Benzoate
* Drug: N-Acetylcysteine
* Drug: Placebo
* Drug: Sodium Benzoate Plus N-Acetylcysteine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male/Female patients aged between 18-35 years. Diagnosis of schizophrenia confirmed by SCID interview meeting DSM-V criteria for schizophrenia, schizophreniform or schizoaffective psychosis. Stable on medication for the past four weeks In contact with mental health services Within 5 years of diagnosis of psychotic illness Able to demonstrate the capacity to provide informed consent as assessed by their own clinician Able to complete the required evaluations and take oral medication. Effective contraceptive precautions (either the use of barrier methods or the oral contraceptive pill) to be taken by women of child-bearing age. A negative pregnancy test will be required in order to meet inclusion criteria. Exclusion Criteria: Prior history of intolerance or serious side effects to Sodium Benzoate or N-acetylcystine. Concomitant use of Ascorbic acid Active substance abuse (except nicotine or caffeine) or dependence within the last three months according to DSM-V criteria. Relevant CNS or other medical disorders. Pregnant or breast feeding Diagnosis of Moderate to Severe Learning Disability Relevant current or past haematological, hepatic, renal, neurological or other medical disorder in the opinion of the principal investigator (PI) or the responsible clinician, that may interfere with the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: This will be a 2x2 factorial design trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sodium Benzoate<br>Sodium Benzoate added to TAU will be administered at 1000mg daily | Drug: Sodium Benzoate<br>* Sodium Benzoate will be administered at 1000mg daily<br>|
| Active Comparator: N-Acetylcysteine<br>N-Acetylcysteine added to TAU 1000 mgs twice daily dose | Drug: N-Acetylcysteine<br>* N-Acetylcysteine 1000 mgs twice daily dose<br>|
| Active Comparator: Placebo<br>Placebo added to TAU | Drug: Placebo<br>* Placebo added to TAU<br>|
| Active Comparator: Sodium Benzoate Plus N-Acetylcysteine<br>Sodium Benzoate will be administered at 1000mg daily and NAC 1000 mgs twice daily dose | Drug: Sodium Benzoate Plus N-Acetylcysteine<br>* Sodium Benzoate will be administered at 1000mg daily and NAC 1000 mgs twice daily dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of intervention ( including recruitment rates and drop outs) | Feasibility estimates of delivering the intervention including recruitment rates and drop outs | Recruitment within 12 months of study start start date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall improvement in symptoms using the Positive and Negative Syndrome Scale (PANSS) total score | The PANSS is measured on a 7-point scale, and is a 30-item structured clinical interview assessing symptom severity over the previous week. The PANSS scale has a maximum score of 210 and a minimum of 30. Higher scores indicate higher severity of illness. | change in scores from Baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Sodium Benzoate, N-Acetylcysteine, NMDA receptor, Psychopharmacology, Anti-oxidant, Inflammation