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

NCT02026947 | Withdrawn Phase 2

• 2 other identifiers: 34183632013-000458-23
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Attenuated or Transient Psychosis

Outcome Measures

Primary Outcomes (2)

• change in PANSS sum score of delusions, hallucinations, suspiciousness, and conceptual disorganization

  change in PANSS sum score of delusions, hallucinations, suspiciousness and conceptual disorganization (the PANSS items that are inclusion criteria)

  baseline - week 12

• change in Clinical Global Improvement Scale (CGIS)

  baseline - week 12

Secondary Outcomes (3)

• change in Clinical Global Improvement (CGI)

  baseline - week 24

• change in Positive and Negative Syndrome Scale (PANSS), Total score

  baseline - week 12

• change in Global Assessment of Functioning (GAF)

  baseline - weeks 12 and 24

Study Arms (2)

Placebo

PLACEBO COMPARATOR

In both arms, one capsule at the morning for the first week. One capsule at the morning and one at the evening for the weeks 2-12.

Drug: Placebo

Sodium benzoate

EXPERIMENTAL

0.5 g/day during the first week, 1.0 g/day for the next 11 weeks. One capsule at the morning for the first week. One capsule at the morning and one at the evening for 2-12 weeks.

Drug: Sodium Benzoate; Drug: Placebo

Interventions

Sodium Benzoate DRUG

0.5 g/day during the first week, 1.0 g/day for the next 11 weeks. One capsule at the morning for the first week. One capsule at the morning and one at the evening for 2-12 weeks.

Sodium benzoate

Placebo DRUG

Placebo; Sodium benzoate

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Niuvanniemi Hospital: lead
• Karolinska Institutet: collaborator

Study Sites (2)

HUS Health Care District

Helsinki, Finland

Location

Varsinais-Suomi and Satakunta Health Care District

Turku, Finland

Location

MeSH Terms

Interventions

Sodium Benzoate

Intervention Hierarchy (Ancestors)

Benzoic Acid; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jari Tiihonen, MD, PhD

  Niuvanniemi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 27, 2013
• First Posted: January 3, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 10, 2014

Record last verified: 2014-04

Locations

FI (2)