Skip to main content
OpenTrials
Completed

NCT Number: NCT03510741

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Schizophrenia Inflammation Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders Schizophreniform Disorders

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Balochistan Institute of Behavioral Science, Quetta, Balochistan, Pakistan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium Benzoate

Drug

Sodium Benzoate will be administered at 1000mg daily

N-acetylcysteine

Drug

N-Acetylcysteine 1000 mgs twice daily dose

Placebo

Drug

Placebo added to TAU

Sodium Benzoate Plus N-Acetylcysteine

Drug

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

Primary outcomes

  1. Feasibility of intervention ( including recruitment rates and drop outs)

    Time frame: Recruitment within 12 months of study start start date

    Feasibility estimates of delivering the intervention including recruitment rates and drop outs

Secondary outcomes

  1. Overall improvement in symptoms using the Positive and Negative Syndrome Scale (PANSS) total score

    Time frame: change in scores from Baseline to 12 weeks

    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.

Other outcomes

  1. Improvement in positive and/or negative symptoms subscales measured using the PANSS.

    Time frame: change in scores from Baseline to 12 weeks

    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.

  2. Improvement on Clinical Global Impression (CGI) Scale and Social and Occupational Functioning Assessment (SOFA) scales.

    Time frame: change in scores from Baseline to 12 weeks

    Clinical Global Impression (CGI) Scale is an observer rated clinical severity measure. The minimum score is 1 and maximum 7. Higher scores indicate severity of illness. Social and Occupational Functioning Assessment (SOFA) scale is a measure of current functioning, with scores ranging from 0 to 100. Higher scores represent higher functioning

  3. Improvement in cognitive functioning as measured using CogState Schizophrenia Battery.

    Time frame: change in scores from Baseline to 12 weeks

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Registry information

Official study title

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.

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 27, 2018
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.