AzTrials
AzTrials

SchizophreniaPhase 2NCT03510741

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

A Phase 2 study testing Sodium Benzoate, N-Acetylcysteine and Sodium Benzoate Plus N-Acetylcysteine in people with Schizophrenia and Schizophreniform Disorders, run by Pakistan Institute of Living and Learning at 5 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years
What is being tested?
Sodium Benzoate, N-Acetylcysteine and Sodium Benzoate Plus N-Acetylcysteine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
5 sitesPakistan
Study dates
1 Jan 2019to 30 Mar 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Pakistan5 sites

  • Abbasi Shaheed Hsopital

    Karachi, Sindh

  • Civil Hospital Karachi

    Karachi, Sindh

  • Karwan e Hayat

    Karachi, Sindh

  • Balochistan Institute of Behavioral Science

    Quetta, Balochistan

  • Institute of Psychiatry, Rawalpindi

    Rawalpindi, Islamabad

Other trials in Pakistan

About this study

Official 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.

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.

Being tested
Sodium Benzoate, N-Acetylcysteine, Placebo, Sodium Benzoate Plus N-Acetylcysteine
Keywords
Schizophrenia, Sodium Benzoate, N-Acetylcysteine, NMDA receptor, Psychopharmacology, Anti-oxidant, Inflammation
Medical subject headings
Schizophrenia, Psychotic Disorders, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium BenzoateDrug

    Sodium Benzoate will be administered at 1000mg daily

  • N-AcetylcysteineDrug

    N-Acetylcysteine 1000 mgs twice daily dose

  • PlaceboDrug

    Placebo added to TAU

  • Sodium Benzoate Plus N-AcetylcysteineDrug

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

Study groups in NCT03510741
Study groupRoleWhat they receive
Sodium BenzoateActive comparatorSodium Benzoate added to TAU will be administered at 1000mg daily
Receives: Drug: Sodium Benzoate
N-AcetylcysteineActive comparatorN-Acetylcysteine added to TAU 1000 mgs twice daily dose
Receives: Drug: N-Acetylcysteine
PlaceboActive comparatorPlacebo added to TAU
Receives: Drug: Placebo
Sodium Benzoate Plus N-AcetylcysteineActive comparatorSodium Benzoate will be administered at 1000mg daily and NAC 1000 mgs twice daily dose
Receives: Drug: Sodium Benzoate Plus N-Acetylcysteine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Recruitment within 12 months of study start start date

Secondary outcomes (1)

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

    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.

    Measured: change in scores from Baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2018
  2. Study start1 Jan 2019
  3. Primary completion30 Dec 2020
  4. Study completion30 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Factorial
Model description
This will be a 2x2 factorial design trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03510741
Sponsor's protocol ID
PILL-Sodium Benzoate & NAC-001
Status last verified
Apr 2022
First submitted
4 Apr 2018
Last updated
27 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Berk M, Copolov D, Dean O, Lu K, Jeavons S, Schapkaitz I, Anderson-Hunt M, Judd F, Katz F, Katz P, Ording-Jespersen S, Little J, Conus P, Cuenod M, Do KQ, Bush AI. N-acetyl cysteine as a glutathione precursor for schizophrenia--a double-blind, randomized, placebo-controlled trial. Biol Psychiatry. 2008 Sep 1;64(5):361-8. doi: 10.1016/j.biopsych.2008.03.004. Epub 2008 Apr 23.

    PubMed 18436195

  • Chaudhry IB, Husain N, Drake R, Dunn G, Husain MO, Kazmi A, Hamirani MM, Rahman R, Stirling J, Deakin W. Add-on clinical effects of simvastatin and ondansetron in patients with schizophrenia stabilized on antipsychotic treatment: pilot study. Ther Adv Psychopharmacol. 2014 Jun;4(3):110-6. doi: 10.1177/2045125313511487.

    PubMed 25057343

  • Farokhnia M, Azarkolah A, Adinehfar F, Khodaie-Ardakani MR, Hosseini SM, Yekehtaz H, Tabrizi M, Rezaei F, Salehi B, Sadeghi SM, Moghadam M, Gharibi F, Mirshafiee O, Akhondzadeh S. N-acetylcysteine as an adjunct to risperidone for treatment of negative symptoms in patients with chronic schizophrenia: a randomized, double-blind, placebo-controlled study. Clin Neuropharmacol. 2013 Nov-Dec;36(6):185-92. doi: 10.1097/WNF.0000000000000001.

    PubMed 24201233

  • Lane HY, Lin CH, Green MF, Hellemann G, Huang CC, Chen PW, Tun R, Chang YC, Tsai GE. Add-on treatment of benzoate for schizophrenia: a randomized, double-blind, placebo-controlled trial of D-amino acid oxidase inhibitor. JAMA Psychiatry. 2013 Dec;70(12):1267-75. doi: 10.1001/jamapsychiatry.2013.2159.

    PubMed 24089054

  • Lin CH, Lin CH, Chang YC, Huang YJ, Chen PW, Yang HT, Lane HY. Sodium Benzoate, a D-Amino Acid Oxidase Inhibitor, Added to Clozapine for the Treatment of Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Trial. Biol Psychiatry. 2018 Sep 15;84(6):422-432. doi: 10.1016/j.biopsych.2017.12.006. Epub 2017 Dec 26.

    PubMed 29397899

  • Chaudhry IB, Hallak J, Husain N, Minhas F, Stirling J, Richardson P, Dursun S, Dunn G, Deakin B. Minocycline benefits negative symptoms in early schizophrenia: a randomised double-blind placebo-controlled clinical trial in patients on standard treatment. J Psychopharmacol. 2012 Sep;26(9):1185-93. doi: 10.1177/0269881112444941. Epub 2012 Apr 23.

    PubMed 22526685

  • Husain MO, Chaudhry IB, Khoso AB, Husain MI, Ansari MA, Mehmood N, Naqvi HA, Nizami AT, Talib U, Rajput AH, Bassett P, Foussias G, Deakin B, Husain N. Add-on Sodium Benzoate and N-Acetylcysteine in Patients With Early Schizophrenia Spectrum Disorder: A Multicenter, Double-Blind, Randomized Placebo-Controlled Feasibility Trial. Schizophr Bull Open. 2024 Feb 9;5(1):sgae004. doi: 10.1093/schizbullopen/sgae004. eCollection 2024 Jan.

    PubMed 39144112

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sodium Benzoate, N-Acetylcysteine and Sodium Benzoate Plus N-Acetylcysteine in people with Schizophrenia and Schizophreniform Disorders, run by Pakistan Institute of Living and Learning at 5 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of intervention ( including recruitment rates and drop outs) (time frame: Recruitment within 12 months of study start start date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03510741, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in