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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03510741
Other study ID # PILL-Sodium Benzoate & NAC-001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 1, 2019
Est. completion date March 30, 2021

Study information

Verified date April 2022
Source Pakistan Institute of Living and Learning
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date March 30, 2021
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 35 Years
Eligibility 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


Intervention

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

Locations

Country Name City State
Pakistan Abbasi Shaheed Hsopital Karachi Sindh
Pakistan Civil Hospital Karachi Karachi Sindh
Pakistan Karwan e Hayat Karachi Sindh
Pakistan Balochistan Institute of Behavioral Science Quetta Balochistan
Pakistan Institute of Psychiatry, Rawalpindi Rawalpindi Islamabad

Sponsors (1)

Lead Sponsor Collaborator
Pakistan Institute of Living and Learning

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Improvement in positive and/or negative symptoms subscales measured using the PANSS. 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. change in scores from Baseline to 12 weeks
Other Improvement on Clinical Global Impression (CGI) Scale and Social and Occupational Functioning Assessment (SOFA) scales. 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 change in scores from Baseline to 12 weeks
Other Improvement in cognitive functioning as measured using CogState Schizophrenia Battery. change in scores from Baseline to 12 weeks
Primary Feasibility of intervention ( including recruitment rates and drop outs) Feasibility estimates of delivering the intervention including recruitment rates and drop outs Recruitment within 12 months of study start start date
Secondary 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. change in scores from Baseline to 12 weeks
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