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

P

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: Sodium Benzoate Plus N-Acetylcysteine
Drug: Placebo

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

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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