Evidence map›Paper›PMID 21939612›Full record

Trial reportThe Journal of clinical psychiatry2011

Time to treatment response in first-episode schizophrenia: should acute treatment trials last several months?

Juan A Gallego, Delbert G Robinson, Serge M Sevy, Barbara Napolitano, Joanne McCormack, Martin L Lesser, John M Kane

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical psychiatry, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00000374 (Preventing Morbidity in First-Episode Schizophrenia), which is not on this map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00000374 phase4completednot on this map

Preventing Morbidity in First-Episode Schizophrenia

TypeinterventionalSponsorNorthwell HealthRan1998 to 2007Enrolled125ConditionsSchizophreniaArmsOlanzapine, Risperidone
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 80 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Juan A GallegoThe Zucker Hillside Hospital, NY 11004, USA. jgallego@nshs.edu
Delbert G Robinson
Serge M Sevy
Barbara Napolitano
Joanne McCormack
Martin L Lesser
John M Kane
Feinstein Institute for Medical Research · USZucker Hillside Hospital · US

Funding

WHITE MATTER STRUCTURAL DEFICITS IN HIGH FUNCTIONING CHILDREN WITH AUTISM SPEM01RR018535 · NCRR · FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH · PI SCHWARTZ, GUY · 2003 to 2010
$19.5M
Striatal D2/D3 Dopamine receptor availability in first episode schizophreniaP50MH080173 · NIMH · FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH · PI GREGERSEN, PETER K. · 2008 to 2012
$10.4M
Trials Operation UnitP30MH074543 · NIMH · FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH · PI KANE, JOHN M · 2005 to 2009
$8.1M
PREVENTING MORBIDITY IN FIRST EPISODE SCHIZOPHRENIAR01MH060004 · NIMH · LONG ISLAND JEWISH MEDICAL CENTER · PI ROBINSON, DELBERT G · 1998 to 2008
$5.2M
Addiction and Subsequent Schizophrenia: A Link?K23DA015541 · NIDA · FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH · PI SEVY, SERGE · 2004 to 2008
$885k
NCRR NIH HHS M01 RR018535NCRR NIH HHS M01RR018535NIDA NIH HHS K23 DA015541NIMH NIH HHS P30 MH074543NIMH NIH HHS P30MH074543NIMH NIH HHS P50 MH080173NIMH NIH HHS R01 MH060004NIMH NIH HHS R01MH 60004
6 · The paper itself

Abstract

objectiveResponse patterns may differ between patients with first-episode and multiepisode schizophrenia. This analysis explored trial duration with first-episode patients and asked whether early limited improvement predicts ultimate lack of treatment response with first-episode patients as it does with multiepisode patients.

methodOne hundred twelve subjects (mean age = 23.3 years, SD = 5.1 years) who presented between November 1998 and October 2004 with a first episode of psychosis and had a DSM-IV diagnosis of schizophrenia or schizophreniform or schizoaffective disorder were randomly assigned to treatment with olanzapine or risperidone for 16 weeks. Treatment response, the primary outcome measure, was defined as a rating of mild or better on all of the positive symptom items on the Schedule for Affective Disorders and Schizophrenia Change Version With Psychosis and Disorganization Items. Response rates were calculated for each study week. A logistic regression analysis examined the association between percentage reduction in symptom severity scores from baseline values at weeks 2, 4, or 8 and response by week 16. The study was conducted at The Zucker Hillside Hospital, Glen Oaks, New York and the Bronx-Lebanon Hospital Center, Bronx, New York.

resultsThe estimated cumulative response rate was 39.59% (95% CI, 29.77%-49.41%) by week 8 and 65.19% (95% CI, 55.11%-75.27%) by week 16. The confidence intervals for estimated response at weeks 10, 12, 14, and 16 were not distinct. Response rates increased approximately 5 to 6 percentage points each 2-week interval between week 10 and 16. Percentage reduction in symptom severity score at week 4 (but not 2 or 8) was associated (χ²₁ = 3.96; P < .05) with responder status at week 16 (odds ratio = 1.03; 95% CI, 1.00-1.05). However, receiver operating characteristic curves did not suggest any level of percentage symptom reduction that would be clinically useful as a predictor of response by week 16.

conclusionsMany first-episode patients respond between weeks 8 and 16 of treatment with a single antipsychotic medication. Limited early symptom improvement does not identify those first-episode patients who will not improve with a full 16-week trial with enough accuracy to be clinically useful.

trial registrationclinicaltrials.gov Identifier: NCT00000374.

Indexed as

AdultAntipsychotic AgentsBenzodiazepinesDrug Administration ScheduleFemaleHumansMaleOlanzapinePsychiatric Status Rating ScalesRisperidoneSchizophreniaSeverity of Illness IndexTime FactorsTreatment OutcomeYoung AdultAntipsychotic AgentsBenzodiazepinesOlanzapineRisperidone

Identifiers

PMID21939612
PMCPMC3246541
OpenAlexW1995582028

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.