Sodium benzoate for treatment of attenuated psychosis

Conditions: attenuated/transient psychosis
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2013-000458-23-FI

Lead Sponsor: iuvannniemi Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 140

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

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.