NCT00014001

Brief Summary

The CATIE Schizophrenia Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The schizophrenia trial is being conducted to determine the long-term effects and usefulness of antipsychotic medications in persons with schizophrenia. It is designed for people with schizophrenia who may benefit from a medication change. The study involves the newer atypical antipsychotics (olanzapine, quetiapine, risperidone, clozapine, and ziprasidone)and the typical antipsychotics (perphenazine and fluphenazine decanoate). All participants will receive an initial comprehensive medical and psychiatric evaluation and will be closely followed throughout the study. For most participants the study will last up to 18 months. Everyone in the study will be offered an educational program about schizophrenia and family members will be encouraged to participate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for phase_4 schizophrenia

Timeline
Completed

Started Dec 2000

Typical duration for phase_4 schizophrenia

Geographic Reach
1 country

54 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2001

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
Last Updated

June 17, 2015

Status Verified

October 1, 2006

First QC Date

April 6, 2001

Last Update Submit

June 16, 2015

Conditions

Keywords

Antipsychotic TreatmentEffectiveness

Interventions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • DSM-IV diagnosis of schizophrenia
  • adequate capacity to consent

You may not qualify if:

  • Intolerance or failure to respond to one of the treatments
  • Diagnoses of schizoaffective disorder, mental retardation, pervasive developmental disorder, delirium, dementia, amnesia
  • First episode of schizophrenia
  • Women currently pregnant or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (54)

Synergy Clinical Research

Chula Vista, California, 91910, United States

Location

LA County-University of Southern California Medical Center

Los Angeles, California, 90033, United States

Location

University of California, Irvine

Orange, California, 92868, United States

Location

University of California,San Diego/VA Medical System

San Diego, California, 92161, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Harbor UCLA Research & Education Institute

Torrance, California, 90502, United States

Location

New Britain General Hospital

New Britain, Connecticut, 06050, United States

Location

Yale University/Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

Mental Health Advocates Inc.

Boca Raton, Florida, 33432, United States

Location

VA Medical Center

Miami, Florida, 33125, United States

Location

University of Miami School of Medicine

Miami, Florida, 33316, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30319, United States

Location

The Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Northwestern Medical School Department of Psychiatry

Chicago, Illinois, 60634, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

University of Iowa Hospital

Iowa City, Iowa, 52242, United States

Location

Psychiatric Research Institute, Outpatient Clinic

Wichita, Kansas, 67214, United States

Location

Louisiana State University Health Services Center

Shreveport, Louisiana, 71130, United States

Location

Clinical Insights, Inc.

Glen Burnie, Maryland, 21061, United States

Location

Massachusetts General Hospital-Freedom Trial Clinic Schizophrenia Program

Boston, Massachusetts, 02114, United States

Location

St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

Corrigan Mental Health Center

Fall River, Massachusetts, 02720, United States

Location

University Of Massachusetts Memorial Health Care

Worcester, Massachusetts, 01605, United States

Location

University of Minnesota School of Medicine

Minneapolis, Minnesota, 55454, United States

Location

University of Mississippi VA Medical Center

Jackson, Mississippi, 39216, United States

Location

University of Missouri Kansas City Medical School

Kansas City, Missouri, 64108, United States

Location

Burrell Behavioral Health-Cox North Hospital

Springfield, Missouri, 65802, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63112, United States

Location

Albuquerque VA Medical Center

Albuquerque, New Mexico, 87124, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

University of Rochester Medical Center

Rochester, New York, 14620, United States

Location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

Mount Sinai Medical Center-Bronx VA Medical Center

The Bronx, New York, 10468, United States

Location

Duke University Medical Center-John Umstead Hospital

Butner, North Carolina, 27509, United States

Location

University of North Carolina School of Medicine

Chapel Hill, North Carolina, 27599, United States

Location

Behavioral Health Center

Charlotte, North Carolina, 28203, United States

Location

Dorothea Dix Hospital

Raleigh, North Carolina, 27603, United States

Location

Appalachian Psychiatric Healthcare System

Athens, Ohio, 45701, United States

Location

North East Ohio Health Services

Beachwood, Ohio, 44122, United States

Location

Philadelphia VA Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Eastern Pennsylvania Psychiatric Institute

Philadelphia, Pennsylvania, 19129, United States

Location

Belmont Center for Comprehensive Treatment

Philadelphia, Pennsylvania, 19131, United States

Location

Veterans Affairs Medical Center

Charleston, South Carolina, 29401, United States

Location

Vanderbilt University Schizophrenia Research

Nashville, Tennessee, 37212, United States

Location

Tri-County MHMR Services

Conroe, Texas, 77304, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Life Management Center for MH/MR Services

El Paso, Texas, 98493, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MHMRA of Harris County-Northwest Community Service Center

Houston, Texas, 77092, United States

Location

The Center for Health Care Services

San Antonio, Texas, 78208, United States

Location

Valley Mental Health Psychopharmacology Research Center

Salt Lake City, Utah, 84117, United States

Location

University of Utah Medical Center

Salt Lake City, Utah, 84132, United States

Location

VA Puget Sound Health Care System

Tacoma, Washington, 98493, United States

Location

Related Publications (48)

  • Davis SM, Koch GG, Davis CE, LaVange LM. Statistical approaches to effectiveness measurement and outcome-driven re-randomizations in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) studies. Schizophr Bull. 2003;29(1):73-80. doi: 10.1093/oxfordjournals.schbul.a006993.

    PMID: 12908662BACKGROUND
  • Keefe RS, Mohs RC, Bilder RM, Harvey PD, Green MF, Meltzer HY, Gold JM, Sano M. Neurocognitive assessment in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project schizophrenia trial: development, methodology, and rationale. Schizophr Bull. 2003;29(1):45-55. doi: 10.1093/oxfordjournals.schbul.a006990.

    PMID: 12908660BACKGROUND
  • Lieberman JA, Stroup TS. Guest editors' introduction: what can large pragmatic clinical trials do for public mental health care? Schizophr Bull. 2003;29(1):1-6. doi: 10.1093/oxfordjournals.schbul.a006979. No abstract available.

    PMID: 12908656BACKGROUND
  • Rosenheck R, Doyle J, Leslie D, Fontana A. Changing environments and alternative perspectives in evaluating the cost-effectiveness of new antipsychotic drugs. Schizophr Bull. 2003;29(1):81-93. doi: 10.1093/oxfordjournals.schbul.a006994.

    PMID: 12908663BACKGROUND
  • Sernyak MJ, Leslie D, Rosenheck R. Use of system-wide outcomes monitoring data to compare the effectiveness of atypical neuroleptic medications. Am J Psychiatry. 2003 Feb;160(2):310-5. doi: 10.1176/appi.ajp.160.2.310.

    PMID: 12562578BACKGROUND
  • Stroup TS, McEvoy JP, Swartz MS, Byerly MJ, Glick ID, Canive JM, McGee MF, Simpson GM, Stevens MC, Lieberman JA. The National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project: schizophrenia trial design and protocol development. Schizophr Bull. 2003;29(1):15-31. doi: 10.1093/oxfordjournals.schbul.a006986.

    PMID: 12908658BACKGROUND
  • Swartz MS, Perkins DO, Stroup TS, McEvoy JP, Nieri JM, Haak DC. Assessing clinical and functional outcomes in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial. Schizophr Bull. 2003;29(1):33-43. doi: 10.1093/oxfordjournals.schbul.a006989.

    PMID: 12908659BACKGROUND
  • Stroup TS, Appelbaum PS. Evaluation of "subject advocate" procedures in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia study. Schizophr Bull. 2006 Jan;32(1):147-52. doi: 10.1093/schbul/sbj026. Epub 2005 Nov 10.

    PMID: 16282635BACKGROUND
  • Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, Keefe RS, Davis SM, Davis CE, Lebowitz BD, Severe J, Hsiao JK; Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005 Sep 22;353(12):1209-23. doi: 10.1056/NEJMoa051688. Epub 2005 Sep 19.

  • McEvoy JP, Lieberman JA, Stroup TS, Davis SM, Meltzer HY, Rosenheck RA, Swartz MS, Perkins DO, Keefe RS, Davis CE, Severe J, Hsiao JK; CATIE Investigators. Effectiveness of clozapine versus olanzapine, quetiapine, and risperidone in patients with chronic schizophrenia who did not respond to prior atypical antipsychotic treatment. Am J Psychiatry. 2006 Apr;163(4):600-10. doi: 10.1176/ajp.2006.163.4.600.

  • Stroup TS, Lieberman JA, McEvoy JP, Swartz MS, Davis SM, Rosenheck RA, Perkins DO, Keefe RS, Davis CE, Severe J, Hsiao JK; CATIE Investigators. Effectiveness of olanzapine, quetiapine, risperidone, and ziprasidone in patients with chronic schizophrenia following discontinuation of a previous atypical antipsychotic. Am J Psychiatry. 2006 Apr;163(4):611-22. doi: 10.1176/ajp.2006.163.4.611.

  • Rosenheck RA, Leslie DL, Sindelar J, Miller EA, Lin H, Stroup TS, McEvoy J, Davis SM, Keefe RS, Swartz M, Perkins DO, Hsiao JK, Lieberman J; CATIE Study Investigators. Cost-effectiveness of second-generation antipsychotics and perphenazine in a randomized trial of treatment for chronic schizophrenia. Am J Psychiatry. 2006 Dec;163(12):2080-9. doi: 10.1176/ajp.2006.163.12.2080.

  • Essock SM, Covell NH, Davis SM, Stroup TS, Rosenheck RA, Lieberman JA. Effectiveness of switching antipsychotic medications. Am J Psychiatry. 2006 Dec;163(12):2090-5. doi: 10.1176/ajp.2006.163.12.2090.

  • Fabbri C, Leggio GM, Drago F, Serretti A. Imputed expression of schizophrenia-associated genes and cognitive measures in patients with schizophrenia. Mol Genet Genomic Med. 2022 Jun;10(6):e1942. doi: 10.1002/mgg3.1942. Epub 2022 Apr 30.

  • Beaudoin M, Hudon A, Giguere CE, Potvin S, Dumais A. Prediction of quality of life in schizophrenia using machine learning models on data from Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial. Schizophrenia (Heidelb). 2022 Mar 21;8(1):29. doi: 10.1038/s41537-022-00236-w.

  • Miller BJ, McEvoy JP, McCall WV. Insomnia, Suicidal Ideation, and Suicide Attempts in the Clinical Antipsychotic Trials of Intervention Effectiveness. J Clin Psychiatry. 2021 Mar 23;82(3):20m13338. doi: 10.4088/JCP.20m13338.

  • Pathak S, Jiang Y, DiPetrillo L, Todtenkopf MS, Liu Y, Correll CU. Course of Psychosis in Schizophrenia With Alcohol Use Disorder: A Post Hoc Analysis of the Clinical Antipsychotic Trials of Intervention Effectiveness in Schizophrenia Phase 1 Study. J Clin Psychiatry. 2020 Mar 17;81(2):19m12731. doi: 10.4088/JCP.19m12731.

  • Ozzoude M, Nakajima S, Plitman E, Chung JK, Kim J, Iwata Y, Caravaggio F, Takeuchi H, Uchida H, Graff-Guerrero A, Gerretsen P. The effects of illness severity, cognition, and estimated antipsychotic dopamine receptor occupancy on insight into the illness in schizophrenia: An analysis of clinical antipsychotic trials of intervention effectiveness (CATIE) data. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Mar 8;89:207-213. doi: 10.1016/j.pnpbp.2018.08.033. Epub 2018 Aug 30.

  • Van Dyke P, Thomas KL. Concomitant calcium channel blocker and antipsychotic therapy in patients with schizophrenia: Efficacy analysis of the CATIE-Sz phase 1 data. Ann Clin Psychiatry. 2018 Feb;30(1):6-16.

  • Xavier RM, Pan W, Dungan JR, Keefe RSE, Vorderstrasse A. Unraveling interrelationships among psychopathology symptoms, cognitive domains and insight dimensions in chronic schizophrenia. Schizophr Res. 2018 Mar;193:83-90. doi: 10.1016/j.schres.2017.07.002. Epub 2017 Jul 8.

  • Bahorik AL, Greeno CG, Cochran G, Cornelius JR, Eack SM. Motivation deficits and use of alcohol and illicit drugs among individuals with schizophrenia. Psychiatry Res. 2017 Jul;253:391-397. doi: 10.1016/j.psychres.2017.04.012. Epub 2017 Apr 5.

  • Moodie EE, Karran JC, Shortreed SM. A case study of SMART attributes: a qualitative assessment of generalizability, retention rate, and trial quality. Trials. 2016 May 14;17(1):242. doi: 10.1186/s13063-016-1368-3.

  • Jakubovski E, Carlson JP, Bloch MH. Prognostic subgroups for remission, response, and treatment continuation in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) trial. J Clin Psychiatry. 2015 Nov;76(11):1535-45. doi: 10.4088/JCP.14m09320.

  • Takeuchi H, Fervaha G, Remington G. Effect of Antipsychotic Dosing Regimen on Neurocognition in Schizophrenia. J Clin Psychopharmacol. 2015 Dec;35(6):728-30. doi: 10.1097/JCP.0000000000000424. No abstract available.

  • Fervaha G, Agid O, Takeuchi H, Lee J, Foussias G, Remington G. Relationship between symptomatic improvement and overall illness severity in patients with schizophrenia. J Clin Psychopharmacol. 2015 Apr;35(2):128-33. doi: 10.1097/JCP.0000000000000286.

  • Fervaha G, Agid O, Takeuchi H, Foussias G, Lee J, Remington G. Clinical and functional outcomes in people with schizophrenia with a high sense of well-being. J Nerv Ment Dis. 2015 Mar;203(3):187-93. doi: 10.1097/NMD.0000000000000266.

  • Fervaha G, Takeuchi H, Lee J, Foussias G, Fletcher PJ, Agid O, Remington G. Antipsychotics and amotivation. Neuropsychopharmacology. 2015 May;40(6):1539-48. doi: 10.1038/npp.2015.3. Epub 2015 Jan 8.

  • Fervaha G, Takeuchi H, Agid O, Lee J, Foussias G, Remington G. Determinants of patient-rated and clinician-rated illness severity in schizophrenia. J Clin Psychiatry. 2015 Jul;76(7):924-30. doi: 10.4088/JCP.14m09128.

  • Fervaha G, Zakzanis KK, Foussias G, Graff-Guerrero A, Agid O, Remington G. Motivational deficits and cognitive test performance in schizophrenia. JAMA Psychiatry. 2014 Sep;71(9):1058-65. doi: 10.1001/jamapsychiatry.2014.1105.

  • Marques TR, Levine SZ, Reichenberg A, Kahn R, Derks EM, Fleischhacker WW, Rabinowitz J, Kapur S. How antipsychotics impact the different dimensions of Schizophrenia: a test of competing hypotheses. Eur Neuropsychopharmacol. 2014 Aug;24(8):1279-88. doi: 10.1016/j.euroneuro.2014.04.001. Epub 2014 Apr 24.

  • Fervaha G, Foussias G, Agid O, Remington G. Motivational and neurocognitive deficits are central to the prediction of longitudinal functional outcome in schizophrenia. Acta Psychiatr Scand. 2014 Oct;130(4):290-9. doi: 10.1111/acps.12289. Epub 2014 May 22.

  • Fervaha G, Agid O, Takeuchi H, Foussias G, Remington G. Effect of antipsychotic medication on overall life satisfaction among individuals with chronic schizophrenia: findings from the NIMH CATIE study. Eur Neuropsychopharmacol. 2014 Jul;24(7):1078-85. doi: 10.1016/j.euroneuro.2014.03.001. Epub 2014 Mar 15.

  • Fervaha G, Foussias G, Siddiqui I, Agid O, Remington G. Abbreviated quality of life scales for schizophrenia: comparison and utility of two brief community functioning measures. Schizophr Res. 2014 Apr;154(1-3):89-92. doi: 10.1016/j.schres.2014.02.013. Epub 2014 Mar 11.

  • Witt K, Hawton K, Fazel S. The relationship between suicide and violence in schizophrenia: analysis of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) dataset. Schizophr Res. 2014 Apr;154(1-3):61-7. doi: 10.1016/j.schres.2014.02.001. Epub 2014 Feb 26.

  • Takeuchi H, Fervaha G, Uchida H, Suzuki T, Bies RR, Gronte D, Remington G. Impact of once- versus twice-daily perphenazine dosing on clinical outcomes: an analysis of the CATIE data. J Clin Psychiatry. 2014 May;75(5):506-11. doi: 10.4088/JCP.13m08695.

  • Bahorik AL, Newhill CE, Queen CC, Eack SM. Letter to the editor: Critique of Bahorik et al. (2013)--'Underreporting of drug use among individuals with schizophrenia: prevalence and predictors'--a reply. Psychol Med. 2014 Feb;44(3):670-1. doi: 10.1017/s0033291713002560. No abstract available.

  • Laber EB, Lizotte DJ, Ferguson B. Set-valued dynamic treatment regimes for competing outcomes. Biometrics. 2014 Mar;70(1):53-61. doi: 10.1111/biom.12132. Epub 2014 Jan 8.

  • Fervaha G, Agid O, Takeuchi H, Foussias G, Remington G. Clinical determinants of life satisfaction in chronic schizophrenia: data from the CATIE study. Schizophr Res. 2013 Dec;151(1-3):203-8. doi: 10.1016/j.schres.2013.10.021. Epub 2013 Nov 1.

  • Fervaha G, Agid O, Takeuchi H, Foussias G, Remington G. Life satisfaction among individuals with schizophrenia in the Clinical Antipsychotic Trial of Intervention Effectiveness (CATIE) study. Am J Psychiatry. 2013 Sep;170(9):1061-2. doi: 10.1176/appi.ajp.2013.13010060. No abstract available.

  • Takeuchi H, Suzuki T, Bies RR, Remington G, Mamo DC, Pollock BG, Mimura M, Uchida H. Estimated dopamine D2 receptor occupancy from plasma concentrations of atypical antipsychotics and subjective experience/drug attitude in schizophrenia: an analysis of the CATIE data. Schizophr Res. 2013 Nov;150(2-3):373-9. doi: 10.1016/j.schres.2013.08.033. Epub 2013 Sep 9.

  • Tsuboi T, Bies RR, Suzuki T, Mamo DC, Pollock BG, Graff-Guerrero A, Mimura M, Uchida H. Hyperprolactinemia and estimated dopamine D2 receptor occupancy in patients with schizophrenia: analysis of the CATIE data. Prog Neuropsychopharmacol Biol Psychiatry. 2013 Aug 1;45:178-82. doi: 10.1016/j.pnpbp.2013.05.010. Epub 2013 May 29.

  • Fervaha G, Remington G. Validation of an abbreviated quality of life scale for schizophrenia. Eur Neuropsychopharmacol. 2013 Sep;23(9):1072-7. doi: 10.1016/j.euroneuro.2012.11.009. Epub 2012 Dec 9.

  • Levine SZ, Rabinowitz J, Faries D, Lawson AH, Ascher-Svanum H. Treatment response trajectories and antipsychotic medications: examination of up to 18 months of treatment in the CATIE chronic schizophrenia trial. Schizophr Res. 2012 May;137(1-3):141-6. doi: 10.1016/j.schres.2012.01.014. Epub 2012 Feb 7.

  • Sakurai H, Bies RR, Stroup ST, Keefe RS, Rajji TK, Suzuki T, Mamo DC, Pollock BG, Watanabe K, Mimura M, Uchida H. Dopamine D2 receptor occupancy and cognition in schizophrenia: analysis of the CATIE data. Schizophr Bull. 2013 May;39(3):564-74. doi: 10.1093/schbul/sbr189. Epub 2012 Jan 30.

  • Levine SZ, Rabinowitz J, Ascher-Svanum H, Faries DE, Lawson AH. Extent of attaining and maintaining symptom remission by antipsychotic medication in the treatment of chronic schizophrenia: evidence from the CATIE study. Schizophr Res. 2011 Dec;133(1-3):42-6. doi: 10.1016/j.schres.2011.09.018. Epub 2011 Oct 14.

  • Addington DE, Mohamed S, Rosenheck RA, Davis SM, Stroup TS, McEvoy JP, Swartz MS, Lieberman JA. Impact of second-generation antipsychotics and perphenazine on depressive symptoms in a randomized trial of treatment for chronic schizophrenia. J Clin Psychiatry. 2011 Jan;72(1):75-80. doi: 10.4088/JCP.09m05258gre. Epub 2010 Sep 21.

  • Caroff SN, Davis VG, Miller DD, Davis SM, Rosenheck RA, McEvoy JP, Campbell EC, Saltz BL, Riggio S, Chakos MH, Swartz MS, Keefe RS, Stroup TS, Lieberman JA; CATIE Investigators. Treatment outcomes of patients with tardive dyskinesia and chronic schizophrenia. J Clin Psychiatry. 2011 Mar;72(3):295-303. doi: 10.4088/JCP.09m05793yel. Epub 2010 Aug 10.

  • Meyer JM, McEvoy JP, Davis VG, Goff DC, Nasrallah HA, Davis SM, Hsiao JK, Swartz MS, Stroup TS, Lieberman JA. Inflammatory markers in schizophrenia: comparing antipsychotic effects in phase 1 of the clinical antipsychotic trials of intervention effectiveness study. Biol Psychiatry. 2009 Dec 1;66(11):1013-22. doi: 10.1016/j.biopsych.2009.06.005. Epub 2009 Jul 29.

MeSH Terms

Conditions

Schizophrenia

Interventions

PerphenazineOlanzapineQuetiapine FumarateRisperidoneziprasidoneClozapinefluphenazine depot

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingDibenzothiazepinesThiazepinesThiepinsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingDibenzazepines

Study Officials

  • Jeffrey A Lieberman, MD

    University of North Carolina

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

April 6, 2001

First Posted

April 9, 2001

Study Start

December 1, 2000

Study Completion

December 1, 2004

Last Updated

June 17, 2015

Record last verified: 2006-10

Locations