Cited by 557Schizophrenia research and treatmentBipolar Disorder and TreatmentMaternal Mental Health During Pregnancy and Postpartum

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Randomized, Double-Blind Trial of Olanzapine Versus Placebo in Patients Prodromally Symptomatic for Psychosis

McGlashan, Thomas H., Zipursky, Robert B., Perkins, Diana, Addington, Jean, Miller, Tandy, Woods, Scott W., A. Hawkins, Keith, E. Hoffman, Ralph, Preda, Adrian, Epstein, Irvin, Addington, Donald, Lindborg, Stacy, Trzaskoma, Quynh, Tohen, Mauricio, Breier, Alan·2006·American Journal of Psychiatry

DOI 10.1176/ajp.2006.163.5.790

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Abstract

OBJECTIVE: This study assessed the efficacy of olanzapine in delaying or preventing conversion to psychosis and reducing symptoms in people with prodromal symptoms of schizophrenia. METHOD: This randomized trial occurred at four North American clinics in the Prevention Through Risk Identification, Management, and Education project. Outpatients received olanzapine (5-15 mg/day, N=31) or placebo (N=29) during a 1-year double-blind treatment period and no treatment during a 1-year follow-up period. Efficacy measures included the conversion-to-psychosis rate and Scale of Prodromal Symptoms scores. RESULTS: During the treatment year, 16.1% of olanzapine patients and 37.9% of placebo patients experienced a conversion to psychosis, a nearly significant difference. The hazard of conversion among placebo patients was about 2.5 times that among olanzapine-treated patients, which also approached significance. In the follow-up year, the conversion rate did not differ significantly between groups. During treatment, the mean score for prodromal positive symptoms improved more in the olanzapine group than in the placebo group, and the mixed-model repeated-measures least-squares mean score showed significantly greater improvement between weeks 8 and 28 with olanzapine. The olanzapine patients gained significantly more weight (mean=8.79 kg, SD=9.05, versus mean=0.30 kg, SD=4.24). CONCLUSIONS: A significant treatment difference in the conversion-to-psychosis rate was not demonstrated. However, these results may be influenced by low power. The nearly significant differences suggest that olanzapine might reduce the conversion rate and delay onset of psychosis. Olanzapine was efficacious for positive prodromal symptoms but induced weight gain. Further treatment research in this phase of illness is warranted.

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Authors: McGlashan, T. H., Zipursky, R. B., Perkins, D., Addington, J., Miller, T., Woods, S. W., A. Hawkins, K., E. Hoffman, R., Preda, A., Epstein, I., Addington, D., Lindborg, S., Trzaskoma, Q., Tohen, M., & Breier, A.
Affiliations: Yale University (US)
ORCID: McGlashan, Thomas H.
Zipursky, Robert B.
Perkins, Diana
Addington, Jean
Woods, Scott W.
Preda, Adrian
Addington, Donald
Lindborg, Stacy
Tohen, Mauricio
Venue: American Journal of Psychiatry
Publisher: American Psychiatric Association Publishing
Published: 2006-05
Volume: 163
Issue: 5
Pages: 790-799
ISSN: 0002-953X (ISSN-L)
1535-7228
DOI: 10.1176/ajp.2006.163.5.790
OpenAlex: W2121366540
Cited by: 556
References: 30
Citations by year: 2026: 4 · 2025: 11 · 2024: 12 · 2023: 7 · 2022: 6 · 2021: 18 · 2020: 21 · 2019: 18 · 2018: 10 · 2017: 12 · 2016: 31 · 2015: 26 · 2014: 28 · 2013: 38 · 2012: 47
FWCI: 32.37
Type: journal article
Language: en
Open access: closed
Locations: American Journal of Psychiatry (publishedVersion)
PubMed (publishedVersion)
Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
Funders: Eli Lilly and Company
University of Toronto
National Institutes of Health (5r24mh054446-05)
National Institute of Mental Health (K05 MH-01654, MH01654, 1 K23 MH01905, K23MH001905, R01MH067073, R01 MH-67073, R24-MH-54446, R02 MH-50557, K05MH001654)
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Maternal Mental Health During Pregnancy and Postpartum
Keywords: olanzapine, transition to psychosis, weight gain, atypical antipsychotics
MeSH terms: Olanzapine, Adolescent, Ambulatory Care, Benzodiazepines, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Obesity, Placebos, Psychiatric Status Rating Scales, Schizophrenia, Schizophrenic Psychology, Severity of Illness Index, Antipsychotic Agents, Weight Gain, Treatment Outcome

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Randomized, Double-Blind Trial of Olanzapine Versus Placebo in Patients Prodromally Symptomatic for Psychosis

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