Clinical trial

Ziprasidone vs Placebo in the Prevention of Psychosis Among Symptomatic Adolescents and Young Adults at Prodromal Risk

Name

0801003386

Description

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

Trial arms

Trial start

2008-03-01

Estimated PCD

2012-11-01

Trial end

2012-11-01

Status

Completed

Phase

Early phase I

Treatment

ziprasidone

20-160 mg/d

Arms:

Ziprasidone

Other names:

Geodon

placebo

Arms:

Placebo

Size

Primary endpoint

Conversion to Psychosis

6 months

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 51, 'type': 'ACTUAL'}}

Updated at

2023-03-27

1 organization

1 product

1 drug

1 indication

Organization

Product

Indication

Drug