Trial reportBMC psychiatry2016
Prolactin related symptoms during risperidone maintenance treatment: results from a prospective, multicenter study of schizophrenia.
Trial report in BMC psychiatry, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00848432 (Risperidone Maintenance Treatment for Relapse Prevention in Schizophrenia), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Risperidone Maintenance Treatment for Relapse Prevention in Schizophrenia
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.
- Antipsychotic dose reduction compared to dose continuation for people with schizophrenia.The Cochrane database of systematic reviews · 2022Pooled it
- Switching antipsychotic medication to reduce sexual dysfunction in people with psychosis: the REMEDY RCT.Health technology assessment (Winchester, England) · 2020Trial
- Quetiapine and Valproic Acid-induced Central Hypothyroidism in a Patient with Autism Spectrum Disorder and Intractable Epilepsy: A Case Report.Endocrine, metabolic & immune disorders drug targets · 2024Article
- Risperidone-Induced Sexual Dysfunction Case Report.Cureus · 2023Article
- Risperidone Induced Hyperprolactinemia: From Basic to Clinical Studies.Frontiers in psychiatry · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis study aimed to investigate prolactin related symptoms (PRS) in individuals with schizophrenia during risperidone maintenance treatment for one year, as well as to identify the risk factors for PRS.
methodsIn a multicenter, randomized, controlled, longitudinal study, clinically stabilized schizophrenia patients (N = 374) were randomized to a no-dose-reduction group (N = 129) and 4-week (N = 125) and 26-week (N = 120) reduction groups, in which the original dose was followed by a 50 % reduction over 8 weeks and subsequently maintained. PRS were assessed via a scale of prolactin related adverse events, which included 16 items: menstrual cycle, menstrual period, menstrual volume, menstrual irregularities, amenorrhea, dysmenorrhea, postpartum lactation, gynecomastia, breast tenderness, sexual dysfunction, decreased sexual desire, erectile dysfunction, ejaculatory dysfunction, impotence, increased body hair, and acne. The occurrence of PRS was assessed at baseline and monthly for six months, followed by every two months. A mixed model was used.
resultsPRS at baseline were reported in 18.4, 15.0, and 14.0 % of the 4-week, 26-week, and no-dose-reduction groups, respectively. Female gender, younger age at onset, and the Positive and Negative Syndrome Scale (PANSS) total scores at entry predicted the development of PRS. The mixed model indicated that PRS were more severe in females and at a high dose. In the 237 patients who remained in the study after one year, the incidence of PRS decreased to 9.6, 11.1, and 7.6 % in the 4-week, 26-week, and no-dose-reduction groups, respectively.
conclusionThese findings indicate that the PRS severity was alleviated during the one year treatment period because of the dose reduction. Attention should focus on the side effects of hyperprolactinemia during long-term treatment, especially with a high dose, females, younger age at onset, and more severe patients.
trial registrationClinicalTrials.gov identifier: NCT00848432 . Registered February 19, 2009.
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