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| Sponsor: | Yale University |
|---|---|
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00635700 |
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 II |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
| 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. | |
| Principal Investigator: | Scott W Woods, MD | Yale University |
More Information
| 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 |
|
psychosis schizophrenia prodrome ziprasidone placebo |
|
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 |