Back to resultsSodium Benzoate and/or N-Acetylcysteine Added to TAU in Patients With Early Schizophrenia Spectrum Disorder.
Primary Purpose
Schizophrenia, Schizophreniform Disorders, Schizoaffective Disorder
Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Sodium Benzoate
N-Acetylcysteine
Placebo
Sodium Benzoate Plus N-Acetylcysteine
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia focused on measuring Schizophrenia, Sodium Benzoate, N-Acetylcysteine, NMDA receptor, Psychopharmacology, Anti-oxidant, Inflammation
Eligibility Criteria
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.
Sites / Locations
- Balochistan Institute of Behavioral Science
- Institute of Psychiatry, Rawalpindi
- Abbasi Shaheed Hsopital
- Civil Hospital Karachi
- Karwan e Hayat
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Sodium Benzoate
N-Acetylcysteine
Placebo
Sodium Benzoate Plus N-Acetylcysteine
Arm Description
Sodium Benzoate added to TAU will be administered at 1000mg daily
N-Acetylcysteine added to TAU 1000 mgs twice daily dose
Placebo added to TAU
Sodium Benzoate will be administered at 1000mg daily and NAC 1000 mgs twice daily dose
Outcomes
Primary Outcome Measures
Feasibility of intervention ( including recruitment rates and drop outs)
Feasibility estimates of delivering the intervention including recruitment rates and drop outs
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03510741
First Posted
April 4, 2018
Last Updated
April 22, 2022
Sponsor
Pakistan Institute of Living and Learning
1. Study Identification
Unique Protocol Identification Number
NCT03510741
Brief Title
Sodium Benzoate and/or N-Acetylcysteine Added to TAU in Patients With Early Schizophrenia Spectrum Disorder.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
March 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizophreniform Disorders, Schizoaffective Disorder
Keywords
Schizophrenia, Sodium Benzoate, N-Acetylcysteine, NMDA receptor, Psychopharmacology, Anti-oxidant, Inflammation
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Model Description
This will be a 2x2 factorial design trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind placebo controlled trial
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium Benzoate
Arm Type
Active Comparator
Arm Description
Sodium Benzoate added to TAU will be administered at 1000mg daily
Arm Title
N-Acetylcysteine
Arm Type
Active Comparator
Arm Description
N-Acetylcysteine added to TAU 1000 mgs twice daily dose
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Placebo added to TAU
Arm Title
Sodium Benzoate Plus N-Acetylcysteine
Arm Type
Active Comparator
Arm Description
Sodium Benzoate will be administered at 1000mg daily and NAC 1000 mgs twice daily dose
Intervention Type
Drug
Intervention Name(s)
Sodium Benzoate
Intervention Description
Sodium Benzoate will be administered at 1000mg daily
Intervention Type
Drug
Intervention Name(s)
N-Acetylcysteine
Intervention Description
N-Acetylcysteine 1000 mgs twice daily dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo added to TAU
Intervention Type
Drug
Intervention Name(s)
Sodium Benzoate Plus N-Acetylcysteine
Intervention Description
Sodium Benzoate will be administered at 1000mg daily and NAC 1000 mgs twice daily dose
Primary Outcome Measure Information:
Title
Feasibility of intervention ( including recruitment rates and drop outs)
Description
Feasibility estimates of delivering the intervention including recruitment rates and drop outs
Time Frame
Recruitment within 12 months of study start start date
Secondary Outcome Measure Information:
Title
Overall improvement in symptoms using the Positive and Negative Syndrome Scale (PANSS) total score
Description
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.
Time Frame
change in scores from Baseline to 12 weeks
Other Pre-specified Outcome Measures:
Title
Improvement in positive and/or negative symptoms subscales measured using the PANSS.
Description
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.
Time Frame
change in scores from Baseline to 12 weeks
Title
Improvement on Clinical Global Impression (CGI) Scale and Social and Occupational Functioning Assessment (SOFA) scales.
Description
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
Time Frame
change in scores from Baseline to 12 weeks
Title
Improvement in cognitive functioning as measured using CogState Schizophrenia Battery.
Time Frame
change in scores from Baseline to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imran B Chaudhry, MD
Organizational Affiliation
Ziauddin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Balochistan Institute of Behavioral Science
City
Quetta
State/Province
Balochistan
Country
Pakistan
Facility Name
Institute of Psychiatry, Rawalpindi
City
Rawalpindi
State/Province
Islamabad
Country
Pakistan
Facility Name
Abbasi Shaheed Hsopital
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
Civil Hospital Karachi
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
Karwan e Hayat
City
Karachi
State/Province
Sindh
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18436195
Citation
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.
Results Reference
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PubMed Identifier
25057343
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.
Results Reference
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PubMed Identifier
24201233
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.
Results Reference
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PubMed Identifier
24089054
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.
Results Reference
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PubMed Identifier
29397899
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.
Results Reference
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PubMed Identifier
22526685
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.
Results Reference
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Sodium Benzoate and/or N-Acetylcysteine Added to TAU in Patients With Early Schizophrenia Spectrum Disorder.
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