PMID- 12648732
OWN - NLM
STAT- MEDLINE
DCOM- 20030804
LR  - 20190916
IS  - 0920-9964 (Print)
IS  - 0920-9964 (Linking)
VI  - 61
IP  - 1
DP  - 2003 May 1
TI  - 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.
PG  - 19-30
AB  - The first double-blind placebo-controlled clinical trial of an atypical 
      neuroleptic medication is being conducted in symptomatic treatment-seeking 
      patients meeting new diagnostic criteria for a putative prodromal syndrome. This 
      identifies them as being at high risk for developing psychosis in the near 
      future. The study aims include prevention of psychosis onset and disability, as 
      well as palliation of ongoing symptomatology. The purpose of this report is to 
      describe the study's "prodromally symptomatic" sample at baseline, i.e., at 
      intake immediately prior to randomization and prior to receiving study 
      medication. Sixty treatment-seeking patients meeting prodromal inclusion criteria 
      were recruited across four sites: New Haven, CT (n=39), Toronto, Ontario (n=9), 
      Calgary, Alberta (n=6), and Chapel Hill, NC (n=6). The sample was young (median 
      age 16), largely male (65%), and came from families with high titers of serious 
      mental illness (44%). Most patients (93%) met criteria for the Attenuated 
      Positive Symptom (APS) prodromal syndrome and presented with significant but 
      nonpsychotic suspiciousness, perceptual aberrations, unusual thought content, and 
      conceptual disorganization. They presented with minimal to mild affective 
      symptoms and substance use/abuse, but they were quite functionally compromised 
      (mean Global Assessment of Functioning (GAF) score=42). The prodromal sample was 
      compared with other clinical-trial samples of adolescent depression, adolescent 
      mania, and first episode schizophrenia. Prodromal patients proved not to be 
      depressed or manic. They were less severely ill than untreated first episode 
      schizophrenia but more severely ill than treated first episode schizophrenia. 
      While not psychotically disabled, these patients nevertheless present with a 
      clinical syndrome. Subsequent reports will detail the effects of drug versus 
      placebo on prodromal symptoms, neuropsychological profile, and the rate of 
      conversion to psychosis.
FAU - Miller, T J
AU  - Miller TJ
AD  - Yale University, New Haven, CT, USA.
FAU - Zipursky, R B
AU  - Zipursky RB
FAU - Perkins, D
AU  - Perkins D
FAU - Addington, J
AU  - Addington J
FAU - Woods, S W
AU  - Woods SW
FAU - Hawkins, K A
AU  - Hawkins KA
FAU - Hoffman, R
AU  - Hoffman R
FAU - Preda, A
AU  - Preda A
FAU - Epstein, I
AU  - Epstein I
FAU - Addington, D
AU  - Addington D
FAU - Lindborg, S
AU  - Lindborg S
FAU - Marquez, E
AU  - Marquez E
FAU - Tohen, M
AU  - Tohen M
FAU - Breier, A
AU  - Breier A
FAU - McGlashan, T H
AU  - McGlashan TH
LA  - eng
GR  - MH01654/MH/NIMH NIH HHS/United States
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - Netherlands
TA  - Schizophr Res
JT  - Schizophrenia research
JID - 8804207
RN  - 0 (Antipsychotic Agents)
RN  - 12794-10-4 (Benzodiazepines)
RN  - 3G0285N20N (Pirenzepine)
RN  - N7U69T4SZR (Olanzapine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antipsychotic Agents/administration & dosage/*therapeutic use
MH  - Benzodiazepines
MH  - Bipolar Disorder/epidemiology
MH  - Comorbidity
MH  - Depressive Disorder, Major/epidemiology
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Mood Disorders/epidemiology
MH  - Olanzapine
MH  - Pirenzepine/administration & dosage/*analogs & derivatives/*therapeutic use
MH  - Psychomotor Disorders/epidemiology
MH  - Psychotic Disorders/epidemiology/genetics/*prevention & control
MH  - Risk Factors
MH  - Schizophrenia/*drug therapy/epidemiology
MH  - Schizophrenic Psychology
MH  - Sleep Wake Disorders/epidemiology
MH  - Speech Disorders/epidemiology
EDAT- 2003/03/22 04:00
MHDA- 2003/08/05 05:00
CRDT- 2003/03/22 04:00
PHST- 2003/03/22 04:00 [pubmed]
PHST- 2003/08/05 05:00 [medline]
PHST- 2003/03/22 04:00 [entrez]
AID - S0920996402004401 [pii]
AID - 10.1016/s0920-9964(02)00440-1 [doi]
PST - ppublish
SO  - Schizophr Res. 2003 May 1;61(1):19-30. doi: 10.1016/s0920-9964(02)00440-1.