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CONCERTA®

(methylphenidate HCl)

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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

CONCERTA® (methylphenidate HCl)
Medical Information

Use in Schizophrenia

Last Updated: 07/15/2026

SUMMARY

  • Lindermayer et al 2013 conducted a systematic review of trials examining the impact of stimulant medications on neurological soft signs (NSS) and their potential adverse effects, finding that agents such as CONCERTA showed neither improvement nor worsening in treating NSS.1
  • Skoretz and Tang 2016 reviewed the potential benefits of CONCERTA in impulse dysregulation in a case series of women with a history of schizophrenia and impulsive violence. The addition of CONCERTA was found to be safe and effective in reducing impulsive violent behavior in this select patient group.2
  • Maeder et al 2022 conducted a non-randomized, open-label study evaluated the impact of CONCERTA on cognitive function and brain connectivity in 25 patients with 22q11.2 deletion syndrome (22q11DS), showing significant reductions in attention-deficit/hyperactivity disorder (ADHD) symptom intensity, particularly inattentive symptoms, and improved attention, inhibition, and processing speed.3,4

PRODUCT LABELING

Please refer to the following section of the enclosed Full Prescribing Information that is relevant to your inquiry: DOSAGE AND ADMINISTRATION, WARNING AND PRECAUTIONS, DRUG INTERACTIONS.5

CLINICAL DATA

Lindermayer et al 2013 conducted a systematic review of trials that examined the impact of stimulant medications on NSS and the potential for adverse effects. In this review, several studies were summarized where the relationship of CONCERTA and schizophrenic symptoms was studied. One study with a cross-over design, which examined the role of CONCERTA in treating NSS, specifically found neither an improvement nor worsening. The authors of this systematic review concluded that psychostimulant medications may be used cautiously in selecting patients with schizophrenia.1

Skoretz and Tang 2016 reviewed the potential benefits of CONCERTA in impulse dysregulation in a case series of women with a history of schizophrenia and impulsive violence. They concluded that CONCERTA may have a role in augmenting effects on clozapine.2

Maeder et al 2022 conducted a non-randomized, open-label study that investigated the effects of CONCERTA on cognitive performance and brain connectivity in patients aged 8-24 years with 22q11DS, a neurogenetic condition associated with a high risk of psychiatric disorders, including schizophrenia spectrum disorders. Twenty-five patients were enrolled and divided into the following 2 groups based on prior CONCERTA use: treatment-naïve patients (n=16) and consumers/chronic users (n=9). CONCERTA treatment significantly reduced overall ADHD symptom intensity, particularly inattentive symptoms, and improved attention, inhibition, and processing speed. However, it showed no significant effects on other executive functions, learning, memory, or daily-life behavioral measures, with only emotional control showing a trend toward improvement.3,4

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 23 September 2025. Older publications (1950-2000) on this topic were also identified by a literature search and are referenced below for your review.6-15

References

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1 Lindenmayer JP, Nasrallah H, Pucci M, et al. A systematic review of psychostimulant treatment of negative symptoms of schizophrenia: Challenges and therapeutic opportunities. Schizophr Res. 2013;147(2-3):241-252.  
2 Skoretz P, Tang C. Stimulants for impulsive violence in schizophrenia spectrum disordered women: a case series and brief review. CNS Spectr. 2016;21(6):445-449.  
3 Janssen Research & Development, LLC. Effects of methylphenidate on brain and cognition in 22q11 deletion syndrome. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 September 23]. Available from: https://www.clinicaltrials.gov/study/NCT04647500 NLM Identifier: NCT04647500.  
4 Maeder J, Mancini V, Sandini C, et al. Selective effects of methylphenidate on attention and inhibition in 22q11.2 deletion syndrome: results from a clinical trial. Int J Neuropsychopharmacol. 2022;25(3):215-225.  
5 CONCERTA (methylphenidate HCl) [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc; https://imedicalknowledge.veevavault.com/ui/approved_viewer?token=7994-edb60a5a-a794-4ed6-b7ab-758d0aa94194
6 Szeszko PR, Bilder RM, Dunlop JA, et al. Longitudinal assessment of methylphenidate effects on oral word production and symptoms in first-episode schizophrenia at acute and stabilized phases. Biol Psychiatry. 1999;45(6):680-686.  
7 Carpenter MD, Winsberg BG, Camus LA. Methylphenidate augmentation therapy in schizophrenia. J Clin Psychopharmacol. 1992;12(4):273-275.  
8 Sharma RP, Javaid JI, Pandey GN, et al. Behavioral and biochemical effects of methylphenidate in schizophrenic and nonschizophrenic patients. Biol Psychiatry. 1991;30(5):459-466.  
9 Robinson D, Mayerhoff D, Alvir J, et al. Mood responses of remitted schizophrenics to methylphenidate infusion. Psychopharmacology (Berl). 1991;105(2):247-252.  
10 Jody D, Lieberman JA, Geisler S, et al. Behavioral response to methylphenidate and treatment outcome in first episode schizophrenia. Psychopharmacol Bull. 1990;26(2):224-230.  
11 Lieberman JA, Kane JM, Gadaleta D, et al. Methylphenidate challenge as a predictor of relapse in schizophrenia. Am J Psychiatry. 1984;141(5):633-638.  
12 Janowsky DS, Huey L, Storms L, et al. Methylphenidate Hydrochloride Effects on Psychological Tests in Acute Schizophrenic and Nonpsychotic Patients. Arch Gen Psychiatry. 1977;34(2):189-194.  
13 Rogeness GA, Macedo CA. Therapeutic response of a schizophrenic boy to a methylphenidate- chlorpromazine combination. Am J Psychiatry. 1983;140(7):932-933.  
14 Janowsky DS, Davis JM. Dopamine, psychomotor stimulants, and schizophrenia: effects of methylphenidate and the stereoisomers of amphetamine in schizophrenics. Adv Biochem Psychopharmacol. 1974;12(0):317-323.  
15 Pargiter RA. Parenteral methylphenidate hydrochloride (ritalin) in chronic underactive schizophrenics. Dis Nerv Syst. 1959;20(2):69-73.  

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