Ziprasidone in the Psychosis Prodrome

Yale University51 enrolled

Overview

This study aims to determine whether ziprasidone is superior to placebo over 24 weeks for patients with the psychosis prodrome.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Psychosis Prodrome

Interventions

ziprasidoneDRUG

20-160 mg/d

placeboDRUG

placebo

Eligibility

Sex: ALLMin age: 16 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Structured Interview for Psychosis-risk Syndromes criteria for Clinical High Risk for Psychosis * clinically referred Exclusion Criteria: * prolonged corrected QT interval * history of syncope

Locations (11)

University of California at San Diego

La Jolla, California, United States

University of California at Los Angeles

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

Conversion to Psychosis

Conversion to psychosis according to the Structured Interview for Psychosis-risk Syndromes (SIPS) require psychotic symptom severity ratings in the frankly psychotic range, along with meeting persistence or urgency criteria.

Time frame: 6 months

Secondary Outcomes

Change in Scale of Psychosis-risk Symptoms Total Score

The Scale of Psychosis-risk Symptoms, a 19-item scale with items scored 0-6. Positive Symptom scores on the SOPS in the 1 to 2 range are considered non-prodromal. Scores of 6 are considered psychotic. Scores in the 3 to 5 range are considered at the clinical high risk level. Minimum value 0. Maximum value 114. Higher score means worse outcome.

Time frame: baseline and 8 weeks

Data from ClinicalTrials.gov

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