attenuated/transient psychosis
Conditions
Interventions
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
Co
Sponsors
Niuvannniemi Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Exclusion criteria: In line with the study by Amminger et al. (2010), the exclusion criteria are: (1) a history of a previous psychotic disorder or manic episode (both treated or untreated); (2) substance-induced psychotic disorder; (3) acute suicidal or aggressive behavior; (4) a current DSM-IV diagnosis of substance dependence (except cannabis dependence); (5) neurological disorders (e.g., epilepsy); (6) IQ of less than 70 (no diagnosis of mental retardation as verified by school performance); (7) previous treatment with an antipsychotic or mood-stabilizing agent (>1 week); (8) pregnancy or inadequate pregnancy prevention, (9) history of allergy or severe adverse events for sodium benzoate; (10) laboratory values more than 10% outside the normal range for transaminases, thyroid hormones, or C-reactive protein; and (11) another severe intercurrent illness that may have put the person at risk or influenced the results of the trial or affected their ability to take part in the trial. Use of benzodiazepine-derivatives is allowed during the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Secondary Objective: Not applicable. ;Primary end point(s): Clinical status ;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable. ;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
Finland
Contacts
Public ContactNiuvanniemi Hospital
Niuvanniemi Hospital
Outcome results
None listed