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OpenTrials
Completed

NCT Number: NCT00635700

Ziprasidone in the Psychosis Prodrome

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

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Key information

Conditions

Psychosis Prodrome Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Calgary, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ziprasidone

Drug

20-160 mg/d

Other names: Geodon

Placebo

Drug

placebo

Primary outcomes

  1. Conversion to Psychosis

    Time frame: 6 months

    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.

Secondary outcomes

  1. Change in Scale of Psychosis-risk Symptoms Total Score

    Time frame: baseline and 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Acronym: ZIP

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 14, 2008
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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