title: Protocol registration and selective outcome reporting in recent psychiatry trials: new antidepressants and cognitive behavioural therapies.
abstract: OBJECTIVE
  The selective reporting of favorable outcomes has a serious influence on our evidence base. However, this problem has not yet been systematically investigated in the field of psychiatry. Our study aimed to evaluate registration and outcome reporting in randomized controlled trials (RCTs) of standard treatments for depression: cognitive behavioural therapy (CBT) or new-generation antidepressants (ADs).
  
  
  METHODS
  We searched for reports of RCTs examining the efficacy of CBT or AD for depression that were published between 2011 and 2013. We then compared their primary outcomes in the trial registries and those in publications.
  
  
  RESULTS
  We identified 170 trials. Among them, 92 trials (54.1%) were registered, 43 trials (25.3%) were properly registered, and only 32 (18.8%) trials were both properly registered and reported (the primary outcomes as recorded in the registries were reported in publications). There was no statistically significant difference in the proportions of properly registered and reported trials for CBT or AD (relative risk: 0.51, 95% CI: 0.25-1.03). High impact factor journals, commercial funding, publication of protocol, and relatively large sample size were significant predictors of proper registration and reporting.
  
  
  CONCLUSIONS
  The prevalence of proper registration and reporting is still very low in depression trials.
authors.affiliation: Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Shinohara
authors.affiliation: Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Tajika
authors.affiliation: Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Imai
authors.affiliation: Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.
authors.forename: N
authors.initials: N
authors.lastname: Takeshima
authors.affiliation: Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Hayasaka
authors.affiliation: Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.
authors.forename: T A
authors.identifier: http://orcid.org/0000-0003-2159-3776
authors.initials: TA
authors.lastname: Furukawa
mesh_terms: D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D001634:Bibliographies as Topic; D015928:Cognitive Behavioral Therapy / Q000706:statistics & numerical data*; D003866:Depressive Disorder / Q000188:drug therapy / Q000628:therapy*; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000592:standards / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic / Q000592:standards / Q000706:statistics & numerical data*; D012042:Registries / Q000592:standards / Q000706:statistics & numerical data*
chemical_list: D018687:Antidepressive Agents, Second-Generation
keywords: antidepressive agents; clinical trials; cognitive therapy; treatment outcome