The PRIME North America randomized double-blind clinical trial of olanzapine versus placebo in patients at risk of being prodromally symptomatic for psychosis I. Study rationale and design
McGlashan TH, Zipursky RB, Perkins D, Addington J, Miller TJ, Woods SW, Hawkins KA, Hoffman R, Lindborg S, Tohen M, Breier A. The PRIME North America randomized double-blind clinical trial of olanzapine versus placebo in patients at risk of being prodromally symptomatic for psychosis I. Study rationale and design. Schizophrenia Research 2003, 61: 7-18. PMID: 12648731, DOI: 10.1016/s0920-9964(02)00439-5.Peer-Reviewed Original ResearchConceptsPsychosis onsetClinical trialsDouble-blind placebo-controlled clinical trialStudy rationaleDouble-blind clinical trialPlacebo-controlled clinical trialAtypical neuroleptic medicationsNew diagnostic criteriaClinical trial designPutative prodromal syndromeTreatment-seeking patientsOngoing symptomatologyNeuroleptic medicationHigh riskDiagnostic criteriaTrial designEarly courseProdromal SyndromesClinical phenomenologyStudy designClinical populationsPatientsOnsetIntervention researchTrialsThe PRIME North America randomized double-blind clinical trial of olanzapine versus placebo in patients at risk of being prodromally symptomatic for psychosis II. Baseline characteristics of the “prodromal” sample
Miller TJ, Zipursky RB, Perkins D, Addington J, Woods SW, Hawkins KA, Hoffman R, Preda A, Epstein I, Addington D, Lindborg S, Marquez E, Tohen M, Breier A, McGlashan TH. The PRIME North America randomized double-blind clinical trial of olanzapine versus placebo in patients at risk of being prodromally symptomatic for psychosis II. Baseline characteristics of the “prodromal” sample. Schizophrenia Research 2003, 61: 19-30. PMID: 12648732, DOI: 10.1016/s0920-9964(02)00440-1.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAntipsychotic AgentsBenzodiazepinesBipolar DisorderComorbidityDepressive Disorder, MajorDouble-Blind MethodFemaleHumansMaleMood DisordersOlanzapinePirenzepinePsychomotor DisordersPsychotic DisordersRisk FactorsSchizophreniaSchizophrenic PsychologySleep Wake DisordersSpeech DisordersConceptsFirst-episode schizophreniaEpisode schizophreniaTreatment-seeking patientsClinical trialsDouble-blind placebo-controlled clinical trialProdromal SyndromesDouble-blind clinical trialPlacebo-controlled clinical trialAtypical neuroleptic medicationsMild affective symptomsNew diagnostic criteriaSerious mental illnessClinical trial samplesUntreated first-episode schizophreniaSubstance use/abuseEffects of drugsPutative prodromal syndromeUse/abuseUnusual thought contentAdolescent maniaOngoing symptomatologyProdromal sampleStudy medicationBaseline characteristicsMost patients