NCT03510741

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Pakistan Institute of Living and Learning · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Schizophrenia
• Schizophreniform Disorders
• Schizoaffective Disorder

Interventions

Type	Name	Description
DRUG	Sodium Benzoate	Sodium Benzoate will be administered at 1000mg daily
DRUG	N-Acetylcysteine	N-Acetylcysteine 1000 mgs twice daily dose
DRUG	Placebo	Placebo added to TAU
DRUG	Sodium Benzoate Plus N-Acetylcysteine	Sodium Benzoate will be administered at 1000mg daily and NAC 1000 mgs twice daily dose

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-12-30
• Completion: 2021-03-30
• First posted: 2018-04-27
• Last updated: 2022-04-27

Locations

5 sites across 1 country: Pakistan