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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Benzoate | Active Comparator | Sodium Benzoate added to TAU will be administered at 1000mg daily |
|
| N-Acetylcysteine | Active Comparator | N-Acetylcysteine added to TAU 1000 mgs twice daily dose |
|
| Placebo | Active Comparator | Placebo added to TAU |
|
| Sodium Benzoate Plus N-Acetylcysteine | Active Comparator | Sodium Benzoate will be administered at 1000mg daily and NAC 1000 mgs twice daily dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Benzoate | Drug | Sodium Benzoate will be administered at 1000mg daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Imran B Chaudhry, MD | Ziauddin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balochistan Institute of Behavioral Science | Quetta | Balochistan | Pakistan | |||
| Institute of Psychiatry, Rawalpindi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18436195 | Background | 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. | |
| 25057343 |
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This will be a 2x2 factorial design trial
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Double-blind placebo controlled trial
| N-Acetylcysteine |
| Drug |
N-Acetylcysteine 1000 mgs twice daily dose |
|
| Placebo | Drug | Placebo added to TAU |
|
| Sodium Benzoate Plus N-Acetylcysteine | Drug | Sodium Benzoate will be administered at 1000mg daily and NAC 1000 mgs twice daily dose |
|
| 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 |
| Improvement in cognitive functioning as measured using CogState Schizophrenia Battery. | change in scores from Baseline to 12 weeks |
| Rawalpindi |
| Islamabad |
| Pakistan |
| Abbasi Shaheed Hsopital | Karachi | Sindh | Pakistan |
| Civil Hospital Karachi | Karachi | Sindh | Pakistan |
| Karwan e Hayat | Karachi | Sindh | Pakistan |
| Background |
| 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. |
| 24201233 | Background | 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. |
| 24089054 | Background | 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. |
| 29397899 | Background | 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. |
| 22526685 | Background | 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. |
| 39144112 | Derived | 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. |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020160 | Sodium Benzoate |
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D019817 | Benzoic Acid |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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