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

Pakistan Institute of Living and Learning

Status and phase: Completed; Phase 2

Conditions: Schizophreniform Disorders; Schizophrenia; Schizoaffective Disorder

Treatments: Drug: N-Acetylcysteine; Drug: Sodium Benzoate; Drug: Placebo; Drug: Sodium Benzoate Plus N-Acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT03510741

PILL-Sodium Benzoate & NAC-001

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.
8. 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

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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64 participants in 4 patient groups

Sodium Benzoate

Active Comparator group

Description:

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

Treatment:

Drug: Sodium Benzoate

N-Acetylcysteine

Active Comparator group

Description:

N-Acetylcysteine added to TAU 1000 mgs twice daily dose

Treatment:

Drug: N-Acetylcysteine

Placebo

Active Comparator group

Description:

Placebo added to TAU

Treatment:

Drug: Placebo

Sodium Benzoate Plus N-Acetylcysteine

Active Comparator group

Description:

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

Treatment:

Drug: Sodium Benzoate Plus N-Acetylcysteine