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

Phase 2

Completed

• Conditions: Schizophreniform Disorders; Schizophrenia; Schizoaffective Disorder
• Interventions: Drug: Placebo; Drug: Sodium Benzoate; Drug: Sodium Benzoate Plus N-Acetylcysteine; Drug: N-Acetylcysteine

• Registration Number: NCT03510741
• Lead Sponsor: Pakistan Institute of Living and Learning

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-04-26
• Study First Posted: 2018-04-27
• Study Start: 2019-01-01
• Primary Completion: 2020-12-30
• Study Completion: 2021-03-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-22
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Feasibility of intervention ( including recruitment rates and drop outs)	Recruitment within 12 months of study start start date	Feasibility estimates of delivering the intervention including recruitment rates and drop outs

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Balochistan Institute of Behavioral Science; 🇵🇰 Quetta, Balochistan, Pakistan

Institute of Psychiatry, Rawalpindi; 🇵🇰 Rawalpindi, Islamabad, Pakistan

Civil Hospital Karachi; 🇵🇰 Karachi, Sindh, Pakistan

Abbasi Shaheed Hsopital; 🇵🇰 Karachi, Sindh, Pakistan

Karwan e Hayat; 🇵🇰 Karachi, Sindh, Pakistan