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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-03-30

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.

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Detailed Description

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Conditions

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Schizophrenia Schizophreniform Disorders Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

This will be a 2x2 factorial design trial

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blind placebo controlled trial

Study Groups

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Sodium Benzoate

Sodium Benzoate added to TAU will be administered at 1000mg daily

Group Type ACTIVE_COMPARATOR

Sodium Benzoate

Intervention Type DRUG

Sodium Benzoate will be administered at 1000mg daily

N-Acetylcysteine

N-Acetylcysteine added to TAU 1000 mgs twice daily dose

Group Type ACTIVE_COMPARATOR

N-Acetylcysteine

Intervention Type DRUG

N-Acetylcysteine 1000 mgs twice daily dose

Placebo

Placebo added to TAU

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Placebo added to TAU

Sodium Benzoate Plus N-Acetylcysteine

Sodium Benzoate will be administered at 1000mg daily and NAC 1000 mgs twice daily dose

Group Type ACTIVE_COMPARATOR

Sodium Benzoate Plus N-Acetylcysteine

Intervention Type DRUG

Sodium Benzoate will be administered at 1000mg daily and NAC 1000 mgs twice daily dose

Interventions

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Sodium Benzoate

Sodium Benzoate will be administered at 1000mg daily

Intervention Type DRUG

N-Acetylcysteine

N-Acetylcysteine 1000 mgs twice daily dose

Intervention Type DRUG

Placebo

Placebo added to TAU

Intervention Type DRUG

Sodium Benzoate Plus N-Acetylcysteine

Sodium Benzoate will be administered at 1000mg daily and NAC 1000 mgs twice daily dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male/Female patients aged between 18-35 years.
2. Diagnosis of schizophrenia confirmed by SCID interview meeting DSM-V criteria for schizophrenia, schizophreniform or schizoaffective psychosis.
3. Stable on medication for the past four weeks
4. In contact with mental health services
5. Within 5 years of diagnosis of psychotic illness
6. Able to demonstrate the capacity to provide informed consent as assessed by their own clinician
7. Able to complete the required evaluations and take oral medication.

Exclusion Criteria

1. Prior history of intolerance or serious side effects to Sodium Benzoate or N-acetylcystine.
2. Concomitant use of Ascorbic acid
3. Active substance abuse (except nicotine or caffeine) or dependence within the last three months according to DSM-V criteria.
4. Relevant CNS or other medical disorders.
5. Pregnant or breast feeding
6. Diagnosis of Moderate to Severe Learning Disability
7. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No