Tolcapone for Obsessive-Compulsive Disorder
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Chicago
Must not be taking: New psychotropics
Disqualifiers: Psychosis, Bipolar, Substance use, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing tolcapone, a medication that may help reduce symptoms of OCD by affecting dopamine levels in the brain. It targets adults with moderate to severe OCD who have significant symptoms. The study also looks at how tolcapone might improve thinking skills and whether genetic differences affect its effectiveness. Tolcapone has been investigated for its potential cognitive benefits in healthy adults.
Do I have to stop taking my current medications for this trial?
The trial allows stable doses of psychotropic medications, so you don't have to stop taking them if they have been stable for at least 3 months before the study.
What data supports the idea that Tolcapone for Obsessive-Compulsive Disorder is an effective drug?
The available research does not provide any data supporting the effectiveness of Tolcapone for Obsessive-Compulsive Disorder. The studies mentioned focus on other drugs and conditions, such as Alzheimer's disease and diabetic neuropathy, without mentioning Tolcapone's impact on Obsessive-Compulsive Disorder.
12345What safety data is available for Tolcapone in treating OCD?
The provided research does not contain any safety data for Tolcapone or its other names related to the treatment of Obsessive-Compulsive Disorder. The studies focus on other medications like trospium chloride and tolterodine for overactive bladder, without mentioning Tolcapone.
678910Is the drug Tolcapone a promising treatment for Obsessive-Compulsive Disorder?
The research articles mainly discuss Tolcapone's use in treating Parkinson's disease and major depressive disorder, but they do not provide specific evidence about its effectiveness for Obsessive-Compulsive Disorder. Therefore, based on the available information, we cannot conclude that Tolcapone is a promising treatment for Obsessive-Compulsive Disorder.
1112131415Eligibility Criteria
This trial is for adults aged 18-65 with moderate to severe Obsessive Compulsive Disorder (OCD), evidenced by a YBOCS score of at least 21. Participants must understand and sign the consent form, not be pregnant or breastfeeding, have no alcohol/substance abuse issues, stable psychotropic medication use if any, normal liver function, and no major cognitive impairments.Inclusion Criteria
YBOCS score of at least 21 at baseline (moderate or higher severity)
I am between 18 and 65 years old.
My primary diagnosis is OCD.
+1 more
Exclusion Criteria
I am not pregnant, breastfeeding, and I use effective birth control.
I can understand and manage my medication, and I can give informed consent.
Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive tolcapone or placebo for 8 weeks, with dosage adjustments after 2 weeks
8 weeks
Weekly visits (in-person)
Cognitive Assessment
Neuropsychological tasks conducted pre- and post-treatment to assess cognitive effects
8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing the effectiveness and safety of Tolcapone in treating OCD. Participants will either receive Tolcapone or a placebo to compare outcomes. The goal is to see if Tolcapone can help reduce the symptoms of OCD more effectively than a non-active treatment.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TolcaponeExperimental Treatment1 Intervention
100mg of tolcapone twice daily for two weeks, then 200mg tolcapone twice daily for the remaining six weeks.
Group II: PlaceboPlacebo Group1 Intervention
100mg of placebo twice daily for two weeks, then 200mg of placebo twice daily for the remaining six weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Chicago Medical CenterChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
References
Double-blind placebo-controlled study of velnacrine in Alzheimer's disease. [2019]The present study assessed the safety and efficacy of the cholinesterase inhibitor, velnacrine, for treating the cognitive symptoms of Alzheimer's disease. Patients (N = 236) meeting NINCDS-ADRDA criteria for Alzheimer's disease entered a double-blind, placebo-controlled dose-ranging protocol (30, 75, 150, 225 mg/day each for one week) to identify velnacrine responders (> or = four point improvement on the cognitive subscale of the Alzheimer's Disease Assessment Scale [ADAScog]). After a two week drug washout, velnacrine responders were randomly assigned to their best velnacrine dose or placebo in a six week dose-replication protocol employing the ADAScog and the Clinical Global Improvement scale as primary outcome measures. During dose-replication, intent-to-treat analysis revealed that velnacrine patients scored significantly better than placebo patients on the ADAScog after two (p
Variation in Placebo Effect Sizes in Clinical Trials of Oral Interventions for Management of the Behavioral and Psychological Symptoms of Dementia (BPSD): A Systematic Review and Meta-Analysis. [2022]Increasing placebo effect sizes over time have been reported in randomized controlled trials (RCTs) for outcomes related to psychiatric symptoms. The Neuropsychiatric Inventory (NPI) is a key outcome measure in clinical trials of the behavioral and psychological symptoms of dementia (BPSD). Accurate placebo effect size estimates for NPI are needed for sample size calculations in order to adequately power future studies. This study investigated variation in placebo effect sizes for NPI in RCTs testing oral interventions for BPSD. A search of PubMed was conducted in April 2016 for two-armed, double-blinded, placebo-controlled RCTs testing any oral intervention for management of BPSD using the NPI. Meta-analysis was conducted of baseline versus end of treatment placebo group data of included studies. Twenty-five RCTs published from 2000 to 2015 were included. Substantial variation in placebo effect sizes was detected. Participants in placebo groups showed greater improvements in recent studies compared with earlier studies. Subgroup analyses indicated robustness of this finding. From 2000 to 2008 there was no significant change in total NPI scores within placebo groups (12 studies; 1,056 participants), whereas from 2009 to 2015 there was significant improvement (mean difference: -2.68; 95% confidence interval: -4.38, -0.99; z = 3.10; p = 0.002, random effects; I2 = 76%; 13 studies; 1,170 participants). This increase in NPI effect sizes in placebo groups has important implications for power calculations for future clinical trials of BPSD. Effect size estimates for NPI need to be based on more recent studies.
Group sequential design and analysis of clinical equivalence assessment for generic nonsystematic drug products. [2007]Clinical trials with therapeutical endpoints are designed with three arms to demonstrate both the efficacy and the equivalence of the test generic treatment and the reference treatment. A generic drug product is determined to be equivalent to the reference drug product if the ratio or difference between the mean responses is bounded within the pre-specified equivalence limits. Often the trials are oversized for the placebo arm. For improvement, we propose a group sequential design with hierarchical testing for the purpose of terminating the placebo arm before testing equivalence between the test and the reference treatments. The hierarchical feature of the proposal will reduce the sample size of the placebo arm and provide treatments to patients in a more efficient manner in a clinical trial setting. After dropping the placebo arm, the option of allocating the planned but unused sample size from the placebo group to the test and reference groups will increase the sample size and power of the equivalence test without inflating the type I error rate by delaying spending it.
Tolrestat in the primary prevention of diabetic neuropathy. [2019]To compare the effects of tolrestat and placebo in patients with subclinical diabetic neuropathy.
Impact of donepezil treatment for Alzheimer's disease on caregiver time. [2019]To assess the impact of donepezil treatment compared with placebo on caregiver time spent assisting patients with Alzheimer's disease (AD).
Efficacy and safety of two doses of tolterodine versus placebo in patients with detrusor overactivity and symptoms of frequency, urge incontinence, and urgency: urodynamic evaluation. The International Study Group. [2019]Tolterodine is a new competitive muscarinic receptor antagonist developed for the treatment of the unstable bladder. A total of 242 patients were enrolled in a multicenter, multinational, randomized, double-blind, placebo-controlled study conducted over a period of 4 weeks in patients with detrusor overactivity and symptoms of frequency, urgency, and urge incontinence. The objective of the study was to compare the efficacy and safety of tolterodine given at 1 or 2 mg b.i.d. versus placebo. At week 4 a statistically significant increase in the volume at first contraction (p = 0.030) and maximal cystometric capacity (p = 0.034) was only in the tolterodine 2 mg b.i.d. group. Tolterodine was safe and generally well tolerated. The incidence of dry mouth, as the most commonly reported adverse event, was only 9% and of mild to moderate intensity.
Once daily trospium chloride is effective and well tolerated for the treatment of overactive bladder: results from a multicenter phase III trial. [2013]An extended release formulation of trospium chloride was recently developed for the once daily treatment of overactive bladder. We investigated the safety, efficacy and tolerability of 60 mg trospium chloride once daily.
Multicenter phase III trial studying trospium chloride in patients with overactive bladder. [2013]To study the efficacy and safety of trospium chloride in treating overactive bladder. Trospium chloride is an anticholinergic agent with predominantly peripheral nonselective antimuscarinic activity and thus has potential therapeutic value in treating patients with overactive bladder.
Effect of tolterodine on sleep structure modulated by CYP2D6 genotype. [2015]Tolterodine, a drug for the treatment of overactive bladder symptoms, has a limited entry into the brain, which makes cognitive side effects seldom. However, some case reports have described central-nervous side effects such as sleepiness. The aim of this retrospective analysis was to investigate whether tolterodine-related effects on sleep stage parameters could be explained by different CYP2D6 metabolizer characteristics of subjects.
Pharmacokinetic and bioequivalence studies of trospium chloride after a single-dose administration in healthy Chinese volunteers. [2022]The study aimed to compare and evaluate the bioequivalence of a new generic preparation of trospium chloride (CAS NO:10405-02-4) capsule (20 mg, test) and the available import tablet (20 mg , reference) for the requirement of state regulatory criteria in China. A randomized- sequence, 2-period crossover study was conducted in 20 healthy Chinese male volunteers in the fasted state. Blood samples were collected before and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 60 h after administration of a single oral dose of 40 mg trospium chloride capsules or tablets, followed by a 7-day washout period. The concentration of trospium chloride was determined by a LC-MS/MS method. Drug And Statistical-Version 2.0 was used to calculate the pharmacokinetics parameters and assess bioequivalence of the two preparations. It was considered bioequivalent if the 90% CIs of the mean ratios (test: reference) for Cmax, AUC0-t and AUC0-∞ were within the range from 80% to 125%, respectively. The main pharmacokinetics parameters of test and reference were as follows: t1/2 was (15.11 ± 3.24) h and (16.00 ± 3.96) h; Tmax was (4.0 ± 1.2) h and (4.1 ± 0.9) h; Cmax was (3.76 ± 1.87) ng·mL - 1 and (3.70 ± 1.89) ng·mL - 1; AUC0-t was (33.51 ± 14.39) ng·mL - 1·h and (33.33 ± 14.88) ng·mL - 1·h, and the AUC0-∞ was (35.20 ± 14.88) ng·mL - 1·h and (35.16±15.17) ng·mL - 1·h. The ratios (test: reference) for Cmax, AUC0-t, and AUC0-∞ were 94.0%~111.7%, 96.4%~106.8%, and 96.1%~105.3%, respectively. No significant differences in pharmacokinetic parameters were found between preparations and periods (p>0.05). No obvious adverse events were monitored throughout the study based on clinical parameters and patient reports.
Integrated pharmacokinetics and pharmacodynamics of the novel catechol-O-methyltransferase inhibitor tolcapone during first administration to humans. [2018]To assess the tolerability, pharmacokinetics and pharmacodynamics of single oral doses of the novel catechol-O-methyltransferase (COMT) inhibitor tolcapone in healthy volunteers.
Tolcapone: a review of its use in the management of Parkinson's disease. [2018]Tolcapone (Tasmar) is a selective, reversible inhibitor of peripheral and central catechol-O-methyltransferase (COMT). Results of well designed studies indicate that oral tolcapone is an effective adjunct to levodopa plus a peripheral dopa-decarboxylase inhibitor (DDCI) in patients with fluctuating Parkinson's disease. Tolcapone significantly improves levodopa-induced motor fluctuations and significantly reduces levodopa requirements. The drug is generally well tolerated, with the most commonly occurring adverse events being dopaminergic related. Thus, tolcapone is a useful option in patients with fluctuating Parkinson's disease who are receiving levodopa/DDCI and are not responding to, or are not candidates for, other adjunctive treatments.
Pharmacokinetics and pharmacodynamics after oral and intravenous administration of tolcapone, a novel adjunct to Parkinson's disease therapy. [2019]To evaluate fully the pharmacokinetics and pharmacodynamics of tolcapone, a novel inhibitor of catechol-O-methyltransferase (COMT), after oral and intravenous administration.
Open study of the catechol-O-methyltransferase inhibitor tolcapone in major depressive disorder. [2019]Tolcapone is a catechol-O-methyltransferase (COMT) inhibitor that has shown efficacy in the treatment of Parkinson's disease. The authors undertook the first study on the efficacy of this COMT inhibitor in the treatment of major depressive disorder (MDD). The authors also wanted to assess the effects of tolcapone on the choline and myoinositol resonances in the left caudate and dorsolateral frontal lobe through proton magnetic resonance spectroscopy and on whole blood levels of S-adenosyl-L-methionine (SAMe). The study enrolled 21 adults (10 men and 11 women; mean age, 42.6 +/- 9.6 years) with MDD, which was diagnosed using the Structured Clinical Interview for DSM-IV, and an initial score of > or = 16 on the 17-item Hamilton Rating Scale for Depression (HAM-D-17). Patients were then treated openly for 8 weeks with tolcapone 400 mg twice daily. Treatment efficacy was assessed with the HAM-D-17, the Clinical Global Impressions Severity (CGI-S) scale, and the Beck Depression Inventory (BDI). Among all subjects (N = 21), there were significant (p
Multiple-dose clinical pharmacology of the catechol-O-methyl-transferase inhibitor tolcapone in elderly subjects. [2019]The purpose of this study was to assess the multiple-dose clinical pharmacology of tolcapone, a novel catechol-O-methyltransferase (COMT) inhibitor, in elderly subjects.