Sodium benzoate for treatment of attenuated/transient psychosis. A randomized placebo-controlled trial

INTERVENTION: Product Name: Sodium benzoate Product Code: E211 Pharmaceutical Form: Capsule INN or Proposed INN: sodium benzoate Other descriptive name: SODIUM BENZOATE Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 1000‐ Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use CONDITION: attenuated/transient psychosis Therapeutic area: Psychiatry and Psychology [F] ‐ Mental Disorders [F03] PRIMARY OUTCOME: Main Objective: The aim of this study is to investigate whether sodium benzoate is superior to placebo in decreasing symptoms among patients with attenuated/transient psychosis. Primary end point(s): Clinical status Secondary Objective: Not applicable. Timepoint(s) of evaluation of this end point: 12 weeks SECONDARY OUTCOME: Secondary end point(s): Not applicable. Timepoint(s) of evaluation of this end point: Not applicable. INCLUSION CRITERIA: 1. Age is from 15 to 30 years 2. Meet criteria for at least 1 of following groups: Group a. Attenuated Psychotic Symptoms: Symptom scores of 3 on the PANSS delusions scale, 2‐3 on the PANSS hallucinations scale, 3‐4 on PANSS suspiciousness, or 3‐4 on PANSS conceptual disorganization scale (frequency of symptoms = 2 times/wk for a period of at least 1 week and not longer than 5 years, to have occurred within the last year) Group b. Transient Psychosis: Symptoms scores of = 4 on PANSS hallucinations scale, = 4 on PANSS delusions scale, or = 5 on PANSS conceptual disorganization scale (symptoms not sustained beyond a week and resolved without antipsychotic medication within the last year) Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range