Methylphenidate ER for Schizophrenia
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: The Royal Ottawa Mental Health Centre
Must be taking: Antipsychotics
Disqualifiers: Hypertension, Cardiovascular, Pregnancy, others
Stay on Your Current Meds
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing whether adding a medication can help improve symptoms in people with schizophrenia. The study involves 24 patients who are already stable on their current medications. The goal is to see if this additional treatment can make a difference in their symptoms.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants can be on any antipsychotic medication, so it seems likely you can continue those.
Is methylphenidate generally safe for humans?
Methylphenidate has been studied for safety in children with ADHD, showing that it is generally well-tolerated, though some adverse reactions (unwanted effects) have been recorded. Dexmethylphenidate, a form of methylphenidate, has also been found to be effective and well-tolerated in clinical trials with children and healthy adults.
12345How does the drug Methylphenidate ER differ from other treatments for schizophrenia?
Methylphenidate ER is unique because it is primarily used for ADHD and works by increasing dopamine and norepinephrine levels, which can actually worsen psychotic symptoms in schizophrenia, unlike typical antipsychotics that aim to reduce these symptoms.
56789Eligibility Criteria
This trial is for adults aged 18-55 with schizophrenia who have been stable for the past 8 weeks and are on antipsychotic medication. They must be able to communicate in English and not have age-related cognitive impairments, sensitivity to methylphenidate ER, significant heart issues, or a history of substance-induced psychosis.Inclusion Criteria
My health condition has been stable for the last 8 weeks.
I have a schizophrenia spectrum illness and am taking antipsychotic medication.
I am between 18 and 55 years old.
+1 more
Exclusion Criteria
I cannot take psychostimulants due to my health conditions or current pregnancy.
Have a history of head injury resulting in loss of consciousness
I have undergone electroconvulsive therapy in the last 6 months.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 4 weeks of methylphenidate ER 36 mg or treatment as usual, followed by a switch in group assignments for another 4 weeks
8 weeks
Weekly visits for assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
1 visit (in-person) at week 12
Participant Groups
The study tests if adding Apo-Methylphenidate ER (a psychostimulant) can help improve negative symptoms and cognitive functions in patients with schizophrenia without causing a relapse or worsening of their condition.
2Treatment groups
Experimental Treatment
Active Control
Group I: Apo-Methylphenidate ER armExperimental Treatment1 Intervention
Apo-Methylphenidate ER, 36 mg, oral, once a day, every morning, 4 weeks duration. Methylphenidate ER will be started at 18 mg to test tolerability and will be titrated at day 7 to a dose of 36 mg.
Group II: Treatment as usual armActive Control1 Intervention
Participants in the treatment as usual arm will continue with their current treatment as decided by their treatment team.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Royal Ottawa Mental Health CentreOttawa, Canada
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Who Is Running the Clinical Trial?
The Royal Ottawa Mental Health CentreLead Sponsor
References
Comparison of the clinical efficacy of twice-daily Ritalin and once-daily Equasym XL with placebo in children with Attention Deficit/Hyperactivity Disorder. [2018]To compare the efficacy and safety of two methylphenidate (MPH) formulations--once-daily modified-release MPH (EqXL, Equasym XL) and twice-daily immediate-release methylphenidate (MPH-IR, Ritalin)--and placebo in children with Attention Deficit/Hyperactivity Disorder (ADHD).
Safety of attention-deficit/hyperactivity disorder medications in children: an intensive pharmacosurveillance monitoring study. [2015]Our intensive pharmacosurveillance monitoring program was performed to increase the number of adverse drug reactions (ADRs) recorded in the Italian spontaneous reporting database, and to systematically collect more thorough data about atomoxetine (ATX) and methylphenidate (MPH) safety in the pediatric setting.
Adverse reactions to methylphenidate treatment for attention-deficit/hyperactivity disorder: structure and associations with clinical characteristics and symptom control. [2013]Methylphenidate (MPH)-related adverse events are well characterized. Their predictors and their relationship with therapeutic effects are less well understood. Here we examine these issues in relation to two long-acting formulations.
An interim analysis of the Quality of Life, Effectiveness, Safety, and Tolerability (QU.E.S.T.) evaluation of mixed amphetamine salts extended release in adults with ADHD. [2019]Evaluate safety and efficacy of mixed amphetamine salts extended release (MAS XR) in adults with attention-deficit/hyperactivity disorder (ADHD).
Dexmethylphenidate--Novartis/Celgene. Focalin, D-MPH, D-methylphenidate hydrochloride, D-methylphenidate, dexmethylphenidate, dexmethylphenidate hydrochloride. [2018]Celgene has developed a chirally pure form of methylphenidate (Ritalin), called dexmethylphenidate [d-methylphenidate, d-methylphenidate hydrochloride, d-MPH; Focalin]. The drug has been launched in the USA and is undergoing registration in Canada for the treatment of children with attention-deficit hyperactivity disorder (ADHD). Dexmethylphenidate is the single isomer version of racemic methylphenidate (Ritalin), which contains the active d isomer of Ritalin. Dexmethylphenidate acts via the inhibition of reuptake of norepinephrine and dopamine. Research is ongoing to further clarify the mode of therapeutic action in ADHD. Dexmethylphenidate was developed with the aim of reducing drug load, adverse events and drug interactions. Dexmethylphenidate provides effective management of attention-deficit hyperactivity disorder at half the dose of Ritalin. In April 2000, worldwide rights (excluding Canada) to dexmethylphenidate were granted to Novartis. Celgene has also granted Novartis rights to all related intellectual properties and patents. Novartis will fund all remaining development and marketing expenses required for regulatory approval and commercialisation of dexmethylphenidate. Crystaal Corporation, the marketing division of Biovail Corporation International, has exclusive Canadian marketing rights for all formulations of dexmethylphenidate. Novartis launched dexmethylphenidate (Focalin) in the USA during Q1 2002. It is available as a D-shaped tablet (2.5, 5 and 10 mg doses). Novartis had planned to use the tradename Ritadex, however the FDA recommended an alternative name due to potential prescribing errors with Ritalin. The finalized tradename to be used is Focalin. In July 2001, a new drug submission was filed with Canada's Therapeutic Products Programme for dexmethylphenidate in the treatment of attention-deficit disorder and attention-deficit hyperactivity disorder. Novartis is also developing an extended-release version of chirally pure dexmethylphenidate. Dexmethylphenidate has been found to be effective and well tolerated in clinical trials, involving a total of 684 children with ADHD and in 15 healthy adult volunteers. Dexmethylphenidate is a schedule II drug.
Reporting a Case of Injecting Methylphenidate (Ritalin) Tablets, Intensified Symptoms of Schizoph-renia or Induce Separate Mental Disorder? [2021]Methylphenidate is one of the classic amphetamines which can cause or exacerbate psychotic symptoms in schizophrenia patients.
Keeping up with the therapeutic advances in schizophrenia: a review of novel and emerging pharmacological entities. [2020]Schizophrenia remains one of the most severe medical diseases. Current dopamine modulating first-generation and second-generation antipsychotics target mainly positive symptoms, but not/inadequately negative and cognitive symptoms. Additional challenges include non-adherence and adverse effects, especially cardiometabolic dysregulation. This review evaluates new/emerging pharmacological treatments for schizophrenia. Therapies targeting total symptoms include cannabidiol, D3 antagonist/5-HT1A partial agonist F17464, lumateperone (ITI-007), phosphodiesterase 10A (PDE10A) inhibitors MK-8189 and TAK-063, sodium nitroprusside, and trace amine-associated receptor-1 (TAAR1) agonist RO5263397 and SEP-363856. Treatments targeting negative symptoms include the PDE10A inhibitor LuAF-11167, 5-HT2A inverse agonist pimavanserin, sigma-2/5-HT2A antagonist roluperidone (MIN-101), and d-amino acid oxidase (DAAO) inhibitor TAK-831. Agents targeting primarily cognitive dysfunction are the glycine transporter-1 inhibitor BI-425809 and cannabidiol. Therapies targeting residual positive symptoms/treatment-resistant schizophrenia include pimavanserin, dopamine D1/D2 antagonist LuAF-35700, and DAAO inhibitor sodium benzoate. Two new long-acting injectable antipsychotic formulations, Aripiprazole Lauroxil NanoCrystal® and the first subcutaneous injectable LAI Perseris (RBP-7000), were recently approved by U.S. Food and Drug Administration, and positive results were announced for Risperidone ISM®, each achieving therapeutic levels within 24 hours, without need for initial oral cotreatment/loading injection-strategies. Paliperidone palmitate 6-monthly intramuscularly injectable and Risperidone subcutaneously injectable TV46000 are currently under investigation. Finally, the samidorphan+olanzapine combination targets reduced weight gain liability, while maintaining olanzapine's efficacy. Most of these trial programs are still ongoing or have yielded mixed or even negative results. Thus, additional mechanisms of action and agents require study to improve schizophrenia outcomes for total/positive symptoms with reduced adverse effects, but also cognitive symptoms, negative symptoms, and treatment resistance, the areas of greatest need in schizophrenia currently.
Longitudinal assessment of methylphenidate effects on oral word production and symptoms in first-episode schizophrenia at acute and stabilized phases. [2019]Some studies have reported psychotic symptom exacerbation during "pharmacologic challenge" paradigms using dopamine agonists. Few studies, however, have examined the effects of these agonists on neurocognitive functions in patients with schizophrenia. This study assessed the effects of methylphenidate infusion on an oral word production test with demonstrated sensitivity to frontal lobe lesions, and on clinical state.
Methylphenidate, dextroamphetamine, and levamfetamine. Effects on schizophrenic symptoms. [2019]Methylphenidate hydrochloride dextroamphetamine sulfate, and levamfetamine succinate have potential as pharmacologic tools for the indirect evaluation of the role of neurotransmitters in schizophrenia. In actively ill schizophrenic patients, methylphenidate administered intravenously causes a brief but clear intensification of preexisting psychotic symptoms, such as hallucinations and delusions. In our study, methylphenidate, dextroamphetamine, and levamfetamine were administered in equimolar doses to schizophrenic patients. Methylphenidate was a more effective activator of symptoms than dextroamphetamine, which in turn was more effective than levamfetamine. Levodopa (L-dopa) given orally also reportedly produces a temporary worsening of schizophrenic symptoms. While these findings augment a body of information suggesting that dopamine and norepinephrine may play a role in the activation of schizophrenic symptoms, our findings with methylphenidate (reportedly weak in eliciting stereotyped behaviour in rat) and our review of the literature indicate complexities that remain to be resolved. There is some utility of the procedure for differential diagnosis and selective therapy, but this is still of occasional and limited potential.