Sodium Benzoate for Treatment of Attenuated/Transient Psychosis. A Randomized Placebo-controlled Trial.

• Status: Withdrawn
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to investigate whether sodium benzoate is superior to placebo in decreasing symptoms among patients with attenuated/transient psychosis. A total of 140 patients will be randomized in 1:1 ratio to receive sodium benzoate 1 g/day or placebo for 12 weeks. Concerning statistical power, the number of patients is sufficient to obtain statistical significance for a clinically meaningful effect size of 0.40 (Cohen's d). The primary outcome measure is change in PANSS sum score of delusions, hallucinations, suspiciousness and conceptual disorganization (the PANSS items that are inclusion criteria) at week 12. Change in CGI score at week 12 is the other primary outcome measure. The secondary outcome measures are change in PANSS total score at week 12, CGI score at week 24, and GAF at weeks 12 and 24.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Niuvanniemi Hospital
• Collaborator: Karolinska Institutet
• Treatments: Sodium Benzoate

Criteria

Inclusion Criteria:

• Age is from 15 to 30 years

• Meet at least 1 criteria for either 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)

Exclusion Criteria:

• a history of a previous psychotic disorder or manic episode (both treated or untreated);

• substance-induced psychotic disorder;

• acute suicidal or aggressive behavior;

• a current DSM-IV diagnosis of substance dependence (except cannabis dependence);

• neurological disorders (e.g., epilepsy);

• IQ of less than 70 (no diagnosis of mental retardation as verified by school performance);

• previous treatment with an antipsychotic or mood-stabilizing agent (>1 week);

• pregnancy or inadequate pregnancy prevention among sexually active females,

• history of allergy or severe adverse events for sodium benzoate;

• laboratory values more than 10% outside the normal range for transaminases, thyroid hormones, or C-reactive protein; and

• 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.