Ziprasidone in the Psychosis Prodrome (ZIP)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Yale University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Yale University
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00635700
First received: March 6, 2008
Last updated: January 13, 2010
Last verified: January 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study aims to determine whether ziprasidone is superior to placebo over 24 weeks for patients with the psychosis prodrome.
| Condition | Intervention | Phase |
|---|---|---|
|
Psychosis Prodrome |
Drug: ziprasidone Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Ziprasidone vs Placebo in the Prevention of Psychosis Among Symptomatic Adolescents and Young Adults at Prodromal Risk |
Resource links provided by NLM:
Further study details as provided by Yale University:
Primary Outcome Measures:
- conversion to psychosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- improvement SOPS total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: ziprasidone
20-160 mg/d
Other Name: Geodon
|
| Placebo Comparator: 2 |
Drug: placebo
placebo
|
Eligibility| Ages Eligible for Study: | 16 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- SIPS criteria for psychosis prodrome
- clinically referred
Exclusion Criteria:
- prolonged QTc
- history of syncope
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00635700
Contacts
| Contact: Scott W Woods, MD | 203 074 7038 | scott.woods@yale.edu |
| Contact: John R Saksa, Psy.D. | 203 974 7043 | john.saksa@yale.edu |
Locations
| United States, California | |
| University of California at San Diego | Recruiting |
| La Jolla, California, United States, 92093 | |
| Contact: Kathy Shafer 619-497-6624 kshafer@ucsd.edu | |
| Contact: Kristin Cadenhead, M.D. 619-725-3537 kcadenhead@ucsd.edu | |
| Principal Investigator: Kristin Cadenhead, M.D. | |
| Sub-Investigator: Nasra Haroun, M.D. | |
| University of California at Los Angeles | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Sandra De Silva, Ph.D. 310-206-6126 desilva@psych.ucla.edu | |
| Contact: Tyrone D Cannon, Ph.D. 310-206-8765 cannon@psych.ucla.edu | |
| Principal Investigator: Tyrone D Cannon, Ph.D. | |
| Sub-Investigator: Melita Daley, M.D. | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Asley Lee 415-476-7560 ashleyl@Lppi.ucsf.edu | |
| Principal Investigator: Demian Rose, M.D., Ph.D. | |
| Sub-Investigator: Daniel Mathalon, M.D., Ph.D. | |
| United States, Connecticut | |
| Yale University School of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06519 | |
| Contact: Barbara Walsh, PhD 203-974-7052 barbara.walsh@yale.edu | |
| Contact: John R Saksa, PsyD 203 974 7043 john.saksa@yale.edu | |
| Principal Investigator: Scott W Woods, MD | |
| Sub-Investigator: Thomas McGlashan, M.D. | |
| Sub-Investigator: Joel Gelernter, M.D. | |
| United States, Georgia | |
| Emory University | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Joy Brasifield 404-727-7547 jbrasfi@emory.edu | |
| Contact: Elaine Walker, Ph.D. 404-727-7547 psyefw@emory.edu | |
| Principal Investigator: Elaine Walker, Ph.D. | |
| Sub-Investigator: Michael Compton, M.D. | |
| United States, Massachusetts | |
| Beth Israel Deaconess Hospital | Not yet recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Ana Carla Oltramari 781-306-8636 aoltramai@challiance.org | |
| Contact: Larry Seidman, Ph.D. lseidman@bidmc.harvard.edu | |
| Principal Investigator: Larry Seidman, Ph.D. | |
| Sub-Investigator: Anthony Giuliano, Ph.D. | |
| Sub-Investigator: Gustavo Kinrys, M.D. | |
| University of Massachusetts | Recruiting |
| Worcester, Massachusetts, United States, 01604 | |
| Contact: Lauren Yakutis 508-856-2407 lauren.yakutis@umassmed.edu | |
| Principal Investigator: Jean Frazier, M.D. | |
| United States, Michigan | |
| Wayne State University School of Medicine | Not yet recruiting |
| Detroit, Michigan, United States, 48201 | |
| Principal Investigator: Rajaprabhakaran Rajarethnam, M.D. | |
| United States, New York | |
| North Shore, Long Island Jewish Health System | Recruiting |
| Glen Oaks, New York, United States, 11004 | |
| Contact: Jenni Atencio, M.A. 718-470-4238 jatencio@nshs.edu | |
| Contact: Barbara A Cornblatt, Ph.D. 718-470-8133 cornblat@lij.edu | |
| Principal Investigator: Barbara A Cornblatt, Ph.D. | |
| Sub-Investigator: Andrea Auther, Ph.D. | |
| Sub-Investigator: Chris Smith, Ph.D. | |
| Sub-Investigator: Christoph Correll, M.D. | |
| United States, North Carolina | |
| University of North Carolina | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Andrea Pelletier 919-843-3421 andrea_pelletier@med.unc.edu | |
| Contact: Karen Graham, M.D. 919-929-2311 karen_graham@unc.edu | |
| Principal Investigator: Karen Graham, M.D. | |
| Sub-Investigator: Diana Perkins, M.D. | |
| Canada, Alberta | |
| University of Calgary | Recruiting |
| Calgary, Alberta, Canada, T2N2T9 | |
| Contact: Geri Anderson 403-944-1050 geri.anderson@calgaryhealthregion.ca | |
| Contact: Donald Addington, M.D. 403-944-1296 addingto@ucalgary.ca | |
| Principal Investigator: Donald Addington, M.D. | |
| Sub-Investigator: Jean Addington, Ph.D. | |
| Sub-Investigator: Thomas Raedler, M.D. | |
Sponsors and Collaborators
Yale University
Investigators
| Principal Investigator: | Scott W Woods, MD | Yale University |
More Information
No publications provided
| Responsible Party: | Scott W. Woods, M.D., Yale University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00635700 History of Changes |
| Other Study ID Numbers: | 0801003386, IIR GA1281GE |
| Study First Received: | March 6, 2008 |
| Last Updated: | January 13, 2010 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Canada: Health Canada Clinical Trials Application control number 120085 |
Keywords provided by Yale University:
|
psychosis schizophrenia prodrome ziprasidone placebo |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features Ziprasidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 22, 2013