Evidence map›Paper›PMID 19102734›Full record

Trial reportBMC psychiatry2008

The effect of antipsychotic medication on sexual function and serum prolactin levels in community-treated schizophrenic patients: results from the Schizophrenia Trial of Aripiprazole (STAR) study (NCT00237913).

Linda Hanssens, Gilbert L'Italien, Jean-Yves Loze, Ronald N Marcus, Miranda Pans, Wendy Kerselaers

3 registry-linked trialsOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC psychiatry, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
4.3field-weighted citation impact, top 6% 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.

NCT00237913 phase3completednot on this map

A Multicenter, Randomized, Naturalistic, Open-Label Study Between Aripiprazole and Standard of Care in the Management of Community-Treated Schizophrenic Patients (Schizophrenia Trial of Aripiprazole - STAR)

TypeinterventionalSponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Ran2004 to 2005Enrolled700ConditionsSchizophreniaArmsAripiprazole, Olanzapine or Quetiapine or Risperidone
NCT01835522 withdrawnnot on this mapstarted 2009, after this paper: background citation

A Survey of Sexual Function in Schizophrenic Patients

TypeobservationalSponsorBeth Israel Medical CenterRan2009 to 2014Enrolled0ConditionsSexual Dysfunction
NCT02472652 phase4terminatednot on this mapstarted 2015, after this paper: background citation

An Open-label Study to Determine the Effect of Switching to Aripiprazole Once Monthly for Subjects With Schizophrenia Experiencing Worsening Sexual Dysfunction With Invega Sustenna or Risperdal Consta

TypeinterventionalSponsorGazda, Thomas D., M.D., PCRan2015 to 2017Enrolled2ConditionsSexual DysfunctionArmsAbilify Maintena
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 85 citations in OpenAlex.

  1. Management of sexual dysfunction due to antipsychotic drug therapy.The Cochrane database of systematic reviews · 2012
    Pooled it
  2. Bromperidol decanoate (depot) for schizophrenia.The Cochrane database of systematic reviews · 2012
    Pooled it
  3. Trial
  4. Article
  5. Review
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  7. Review
  8. Article
  9. Article
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  13. Article
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  15. Review
  16. Prolactin serum concentrations during aripiprazole treatment in youth.Journal of child and adolescent psychopharmacology · 2013
    Review
  17. Antipsychotic-induced sexual dysfunction and its management.The world journal of men's health · 2012
    Article
  18. Article
  19. Review
  20. Article
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

6 authors at 3 institutions in 4 countries.

Linda HanssensBristol-Myers Squibb Company, Parc de l'Alliance, Avenue de Finlande, 8, B-1420 Braine-l'Alleud, Belgium. linda.hanssens@bms.com
Gilbert L'Italien
Jean-Yves Loze
Ronald N Marcus
Miranda Pans
Wendy Kerselaers
Bristol-Myers Squibb (Germany) · DEBristol-Myers Squibb (United States) · USOtsuka (France) · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim of this paper is to evaluate the effect of antipsychotics for the treatment of schizophrenia in a community based study on sexual function and prolactin levels comparing the use of aripiprazole and standard of care (SOC), which was a limited choice of three widely used and available antipsychotics (olanzapine, quetiapine or risperidone) (The Schizophrenia Trial of Aripiprazole [STAR] study [NCT00237913]).

methodThis open-label, 26-week, multi-centre, randomised study compared aripiprazole to SOC (olanzapine, quetiapine or risperidone) in patients with schizophrenia (DSM-IV-TR criteria). The primary effectiveness variable was the mean total score of the Investigator Assessment Questionnaire (IAQ) at Week 26. The outcome research variables included the Arizona Sexual Experience scale (ASEX). This along with the data collected on serum prolactin levels at week 4, 8, 12, 18 and 26 will be the focus of this paper.

resultsA total of 555 patients were randomised to receive aripiprazole (n = 284) or SOC (n = 271). Both treatment groups experienced improvements in sexual function from baseline ASEX assessments. However at 8 weeks the aripiprazole treatment group reported significantly greater improvement compared with the SOC group (p = 0.007; OC). Although baseline mean serum prolactin levels were similar in the two treatment groups (43.4 mg/dL in the aripiprazole group and 42.3 mg/dL in the SOC group, p = NS) at Week 26 OC, mean decreases in serum prolactin were 34.2 mg/dL in the aripiprazole group, compared with 13.3 mg/dL in the SOC group (p < 0.001).

conclusionThe study findings suggest that aripiprazole has the potential to reduce sexual dysfunction, which in turn might improve patient compliance.

Indexed as

Schizophrenic PsychologyAdultAntipsychotic AgentsAripiprazoleBenzodiazepinesDibenzothiazepinesFemaleHumansMaleOlanzapinePatient SatisfactionPiperazinesProlactinQuality of LifeQuetiapine FumarateQuinolonesAntipsychotic AgentsAripiprazoleBenzodiazepinesDibenzothiazepinesOlanzapinePiperazinesProlactinQuetiapine FumarateQuinolonesRisperidone

Identifiers

PMID19102734
PMCPMC2637262
OpenAlexW1987902149

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.