Mean (SD) changes from baseline by prior treatment groups were −53.9 (23.7), −51.4 (24.5), and −45.9 (29.4) for the placebo (n = 31), memantine full-dose (n = 34), and memantine reduced-dose (n = 41), respectively. In MEM-MD-91, 517 (59.6%) participants were confirmed Social Responsiveness Scale responders at week 12; mean Social Responsiveness Scale total raw scores improved two to three times a minimal clinically important difference of 10 points. MEM-MD-68 was carried out in full compliance with the guidelines of the IECs and national health authorities of Belgium, Colombia, Estonia, France, Hungary, Iceland, Italy, New Zealand, Poland, South Korea, Serbia, South Africa, Spain, and Ukraine. At week 9 (first post-baseline SRS assessment), 543 (62.6%) responded to treatment and 517 (59.6%) were confirmed SRS responders. In the reduced-dose arm, the weight-based memantine dose received in MEM-MD-91 was reduced by ⩾50%. Baseline scores were intermediate in the open-label follow-on study (MEM-MD-69), possibly reflecting regression to the mean among the participants in MEM-MD-68. This is not a complete list of possible side effects. ITT: intention-to-treat, LTR: loss of therapeutic response. Adderall may affect your or your child's ability to drive or do other dangerous activities. Participants who completed MEM-MD-68 or who discontinued due to loss of therapeutic response (LTR)—defined as a ⩾10-point increase in SRS total raw score at any double-blind visit versus SRS score at randomization—were eligible to enroll into the long-term open-label safety study, MEM-MD-69. Memantine adhd. Mean (SD) changes from baseline at week 12 in SRS total raw scores ranged from −8.0 (10.0) in the placebo-treated Asperger’s group to −25.7 (18.4) in the full-dose Asperger’s group (Table 2). Side effects of Namenda that are different from Adderall include tiredness, body aches, joint pain, swelling in your hands or feet, easy bruising or bleeding, aggression, skin rash, redness or swelling of or around your eyes, or urinating more than usual. Sharing links are not available for this article. Namenda and Adderall belong to different drug classes. Only episodic use of local anesthetics, antacids, antibiotics, antidiarrheal preparations, antinauseants (phosphoric acid preparations only), antiviral agents (only Zovirax, Valtrex, and Famvir), cough/cold preparation (except dextromethorphan), and vaccines was allowed. This is a 12-week clinical trial evaluating the efficacy and safety of memantine hydrochloride (Namenda) in the treatment of executive function deficits (EFDs) in adults with Attention Deficit Hyperactivity Disorder (ADHD) receiving open-label treatment with OROS-Methylphenidate (OROS-MPH, Concerta). While high expectations may have contributed to higher SRS scores in the placebo group, regression to the mean may have contributed to lower scores. Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Hyperactivity disorder and attention deficit are common neurological disorders in children and adolescents. In the chapter about mediations, he talks about the possibility of using the amantadine to treat ADHD. Most TEAEs were mild to moderate in intensity. Memantine is a prescription drug. This randomized-withdrawal study was designed per FDA Guidance for Industry E11 Clinical Investigation of Medicinal Products in the Pediatric Population. For MEM-MD-91 and MEM-MD-69, exploratory efficacy measures were evaluated using descriptive statistics for all continuous variables (SRS total raw score and subscales, ABC subscales, and CCC-2 subscales) and frequency distributions (number and percentage) for categorical variables (CGI-severity (CGI-S) and CGI-I subscales) by weight group using an observed case approach. Any missing drug warnings or information does not in any way guarantee the safety, effectiveness, or the lack of adverse effects of any drug. The reasons for the large improvement are unclear. By the end of the study, there was a mean ± SD decrease (improvement) in SRS total raw score of 32.4 ± 26.4 from baseline of the first lead-in study (N = 747; safety population and observed cases). - posted in Brain Health: I am trying another trial run with memantine for help with methylphenidate for my ADHD. It is unknown if this drug passes into breast milk. Three phase 2 trials were conducted to assess the efficacy and long-term safety of weight-based memantine extended release (ER) treatment in children with autism spectrum disorder. The total of 70 items (seven per subscale) is rated from 0 to 3 with higher scores indicating greater impairment. This suggests that the memantine doses used in these ASD studies were possibly inadequate for most trial participants, despite results from a population pharmacokinetic study that suggested the appropriateness of the weight-based memantine ER dosing (Carrothers, Periclou, Khariton, & Ghahramani, 2014). OBJECTIVE: To evaluate the efficacy and safety of memantine hydrochloride as an adjunct to stimulant pharmacotherapy for treating executive function deficits (EFDs) in adults with ADHD. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). If the address matches an existing account you will receive an email with instructions to reset your password The dose of drugs with central nervous system activity must have been stable for at least 30 days prior to screening and were to remain stable throughout the study. Ask your doctor or pharmacist for more information. The SRS measures the severity of social communication deficits as they occur in natural environments. A similar proportion of participants in each treatment group experienced LTR during the 12-week treatment period: 69.0% placebo, 66.7% full-dose, and 67.5% reduced-dose memantine (ITT). At study end, the mean (SD) SRS total raw score for all participants was 79.2 (28.2); the 25th, 50th, and 75th percentiles were 59.0, 78.0, and 99.5 (Table 2). Overall, 30.1% completed the study and 65.8% discontinued due to LTR (Supplemental Material 2). Participants randomized to placebo were switched from their weight-based open-label memantine dose to placebo at randomization. Baseline demographics were generally comparable across ASD subtypes (Supplemental Material 1), and 83.8% of participants were taking concomitant medications and supplements, most commonly (⩾10.0%) melatonin (17.0%), multivitamin (15.9%), ibuprofen (11.4%), risperidone (10.6%), and paracetamol (10.3%). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. While the a priori–defined efficacy results of the double-blind trial were not achieved, the considerable improvements in mean Social Responsiveness Scale scores from baseline in the open-label trials were presumed to be clinically important. The recommended starting dose of Namenda is 5 mg once daily. Namenda (memantine hydrochloride) is an orally active NMDA receptor antagonist used to treat moderate to severe Alzheimer's type dementia. Figure 5. Figure 6. (. Drug information found in the drug comparisons published on RxList.com is primarily sourced from the FDA drug information. Due to the time-sensitive nature of drug information, RxList.com makes no guarantees that the information provided is the most current. In one study on children diagnosed with ADHD, it was found that both 10 mg/day and 20 mg/day of Memantine led to improvements in ADHD symptoms. In MEM-MD-68, there was no difference between memantine and placebo on the primary efficacy parameter, the proportion of patients with a loss of therapeutic response (defined as ⩾10-point increase from baseline in Social Responsiveness Scale total raw score). Namenda may also interact with cimetidine, nicotine, ranitidine, quinidine, antiviral medications, cold or cough medicines containing dextromethorphan, medicines to treat glaucoma, or oral diabetes medicines containing metformin. Use of the following concomitant medications was not allowed within five half-lives or 4 weeks of screening, whichever was shorter: NMDA antagonists (e.g. A total of 64% of participants had ⩾1 treatment-emergent adverse event (TEAE) (34.3% mild, 27.7% moderate, and 2.0% severe intensity) with similar incidences across ASD subtypes; the most commonly reported TEAEs (>5.0%) were headache, nasopharyngitis, pyrexia, and irritability (Table 3). If you have access to a journal via a society or association membership, please browse to your society journal, select an article to view, and follow the instructions in this box. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. For more information view the SAGE Journals Sharing page. It is approved to treat moderate to severe Alzheimer's type dementia. In addition to trials MEM-MD-57A and MEM-MD-67 described above, three clinical trials also included under the PWR (MEM-MD-91, MEM-MD-68, and MEM-MD-69) further examined the safety, tolerability, and efficacy of memantine ER in individuals with autistic disorder, Asperger’s disorder, or PDD-NOS. confirmed responder) were eligible to transition to randomized trial MEM-MD-68. The abbreviated term ADHD denotes the condition commonly known as: 6 Parenting Tips for Raising Kids With ADHD. (, Benedetti, F., Carlino, E., Piedimonte, A. it strongly correlates with Diagnostic and Statistical Manual of Mental Disorders (DSM) criterion scores) (Constantino et al., 2003) and has been found to have good internal consistency reliability and test–retest reliability in younger and older individuals (Pine, Luby, Abbacchi, & Constantino, 2006). The SRS is a 65-item caregiver-rated assessment consisting of five subscales to assess social abilities: social awareness, social cognition, social communication, social motivation, and autistic mannerisms. Millions of children (and adults) are taking these drugs and while life-saving at times, there are plenty who seek alternatives to Adderall. Because of the design and sequence of the three studies, SRS scores at baseline were substantially higher in the lead-in open-label study (MEM-MD-91) than in the double-blind withdrawal study (MEM-MD-68), which is selected for stabilized responders from MEM-MD-91. An independent Data and Safety Monitoring Board (DSMB) reviewed safety data at defined intervals throughout each study. Do not start any new medicine while taking Adderall without talking to your doctor first. Extended-release (ER) memantine monotherapy was investigated in children with autistic disorder, Asperger’s disorder, or PDD-NOS as part of a phase 2 clinical development program designated under the US FDA Pediatric Written Request (PWR). METHOD: This was a 12-week, double-blind, placebo-controlled, randomized clinical trial of memantine added to open-label treatment with stimulant medication. Approximately 75% of all participants achieved ⩾10-point improvement in SRS total raw score (Figure 4(a)). A numerically greater proportion of placebo-treated participants with autistic disorder experienced LTR (73.0%) versus full-dose (64.3%) and reduced dose (66.7%), indicating a trend in favor of memantine ER for this ASD subtype. Memantine and ADHD. For MEM-MD-91, efficacy analyses were exploratory and based on the ITT population (all who received ⩾1 open-label memantine-ER dose and had ⩾1 follow-up assessment that included a valid SRS during treatment). By the way, I have seen the changes in how ADHD is treated over the years. Adderall may also interact with heart or blood pressure medications, cold or allergy medicines (antihistamines), acetazolamide, chlorpromazine, ethosuximide, haloperidol, lithium, meperidine, methenamine, phenytoin, phenobarbital, reserpine, ammonium chloride, ascorbic acid (vitamin C), potassium phosphate, antacids, potassium citrate, sodium citrate and citric acid, sodium citrate and potassium, stomach acid reducers, or antidepressants. The aim of this study is to evaluate the effect of memantine in improving RD in children. Namenda (memantine hydrochloride) and Adderall (amphetamine and dextroamphetamine salts) are used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy. SRS total raw scores at baseline were similar between autistic disorder and PDD-NOS subgroups, but numerically higher in those with Asperger’s disorder (Supplemental Material 1). (, Owley, T., Salt, J., Guter, S., Grieve, A., Walton, L., Ayuyao, N., . Dose increases for concomitant medications were prohibited during the study, but dose reductions were allowed upon consultation with the Sponsor Study Physician. A total of 84.3% of participants were taking concomitant medications and supplements, most commonly (⩾10.0%) multivitamins (14.7%), ibuprofen (13.0%), paracetamol (11.7%), risperidone (10.2%), and loratadine (10.1%). (, Parsons, C. G., Stoffler, A., Danysz, W. (, Pine, E., Luby, J., Abbacchi, A., Constantino, J. N. (, Spencer, A. E., Uchida, M., Kenworthy, T., Keary, C. J., Biederman, J. The three phase 2 studies described in this article (MEM-MD-91, NCT01592786; MEM-MD-68, NCT01592747; MEM-MD-69, NCT01592773) were conducted between June 2012 and August 2014 at multiple global centers in pediatric outpatients with autistic disorder, Asperger’s disorder, or PDD-NOS as defined by the Diagnostic and Statistical Manual of Mental Disorders (4th ed., text rev. Lean Library can solve it. As altered changes in glutamatergic signaling have been observed in pediatric individuals with ASD (Choudhury, Lahiri, & Rajamma, 2012; Rojas, 2014; Spencer et al., 2014), interventions that modulate glutamate receptors may therefore be of therapeutic benefit. MEM-MD-69 was an open-label extension trial in which participants from MEM-MD-68, MEM-MD-91, and open-label trial MEM-MD-67 were treated ⩽48 weeks with memantine extended release. Future studies may consider possible instrument-specific effects and an MCID, as well as potential caregiver biases and expectations suggested by these results. All studies utilized the SRS (Constantino et al., 2003; Constantino & Gruber, 2012), the Children’s Communication Checklist, Second Edition (CCC-2) (Bishop, 2006), the CGI (Guy, 1976), and the Aberrant Behavior Checklist–Community Version (ABC-C) (Aman, Singh, Stewart, & Field, 1985). The study protocols and amendments, informed consent forms, and information sheets were approved by the IECs at each study center in conformance with US CFR, Title 21, Part 56, the European Union Clinical Trial Directive 2001/20/EC (if applicable), and local regulations. amantadine, ketamine, and dextromethorphan), general anesthetics, antianginal agents, antiarrhythmics, anticoagulants, systemic antifungal agents, antineoplastics, the antiviral agents Symmetrel and Endantadine, diuretics, hormone suppressants, H2 blockers, hypoglycemic agents, hypolipidemics, insulin, and systemic steroids. Dosage is increased in 5 mg increments to 10 mg/day (5 mg twice a day), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice a day). Using the same methodology as specified in the original CGI (Guy, 1976), the CGI rater was a clinician who provided a global impression of severity (CGI-S) based on overall severity, as well as on each of the domains of social interaction, communication, integrated social interaction and communication, stereotyped behaviors and restricted interests, associated maladaptive behaviors, and daily function. Forty children with ADHD (double-blind randomized controlled trial) were treated with either methylphenidate, a drug used to treat ADHD, or memantine, for 6 weeks. Tell your doctor all prescription and over-the-counter medications you use. Similar percentages of participants with autistic disorder (83.3%), Asperger’s disorder (88.1%), and PDD-NOS (86.6%) completed the study. Treatment emergent adverse events ⩾3% in any treatment group (safety population). Mean duration of exposure was comparable across treatment groups (Table 2), and 80.9% of participants were taking concomitant medications and supplements, most commonly (⩾10.0%) melatonin (16.4%), multivitamin (13.4%), and loratadine (10.1%). Sensitivity of the modified Children’s Yale–Brown Obsessive Compulsive Scale to d... Current Approaches to the Pharmacologic Treatment of Core Symptoms Acr... Overlapping Molecular Pathways Leading to Autism Spectrum Disorders, F... An Examination of Changes in Urinary Metabolites and Behaviors with th... Aman, M. G., Findling, R. L., Hardan, A. Y., Hendren, R. L., Melmed, R. D., Kehinde-Nelson, O., . Although the maximal weight-based dose groups were identified in Part 1 of the MEM-MD-57A trial (N = 12), a previous pilot study of memantine found that memantine doses 10–20 mg/day were well tolerated in pediatric ADHD participants with the 20 mg/day dose conferring greater improvement on efficacy measures than the 10 mg/day dose (Findling et al., 2007). No new safety concerns were evident. A clinically significant improvement of ⩾10 points from baseline in SRS total raw scores was evident in both the full- and reduced-dose memantine groups; however, most placebo-treated groups also reported clinically meaningful improvements (excepting placebo-treated participants in the Asperger’s group). The CGI-I was similarly conducted on overall improvement, as well as the domains of social interaction, communication, integrated social interaction and communication, stereotyped behaviors and restricted interests, associated maladaptive behaviors, and daily function. Despite not achieving a priori endpoints, the double-blind, controlled trial (MEM-MD-68) along with its open-label lead-in study (MEM-MD-91) and the long-term open-label safety study (MEM-MD-69) were successful in many ways. Your doctor may do regular checks of the blood, heart, and blood pressure while taking
The study aims to examine the effects of treatment with memantine on ADHD symptoms. The most common TEAEs were irritability, vomiting, agitation, and anxiety (Table 3). Clinical trials in children with ASD may be particularly challenging given the heterogeneity of the disorder, including the range of symptom severity and multifaceted presentation in each individual. Yes, the little one could have ADHD. Figure 7. Assessment of global functioning in adolescents with autism spectrum disorders: Utility of the ... Psychopharmacology of autism spectrum disorders: A selective review. Having spent almost 40 years in the classroom. The percentage of confirmed responders was similar between autistic disorder (57.4%) and Asperger’s disorder (60.9 %) and numerically greater in PDD-NOS (66.7%). Therefore, the findings reported here are unlikely to change while using either the SD or the SEM as threshold for change on the SRS. For MEM-MD-68, the primary efficacy parameter—proportion of participants with LTR on the SRS by study end—was analyzed using the Cochran–Mantel–Haenszel test, controlling for ASD subtype. Like MEM-MD-57A and MEM-MD-67, memantine-ER was administered over a limited, weight-based dose range (3–15 mg/day). The ratings for CGI-I range from 1 (marked improvement) to 7 (marked worsening). Conducting clinical trials in children is fraught with many operational, physiological, and ethical challenges (Kern, 2009). A total of 160 participants were randomized to placebo, 158 to their full memantine dose received during MEM-MD-91 and 161 to a reduced memantine dose (at least 50% reduction). Call your doctor for medical advice about side effects. Login failed. Namenda is an orally active NMDA receptor antagonist and Adderall is an amphetamine. One or two more doses may be taken during the day, 4 to 6 hours apart. The results presented here underscore the need to develop an MCID for the SRS and SRS subscales to fully characterize response to treatment, as has been done for instruments in other therapeutic areas. The statistically insignificant findings of the double-blind, placebo-controlled trial of memantine ER in ASD individuals presented here are no exception. Memantine is an N-Methyl-D-Aspartic Acid (NMDA) receptor antagonist, approved by the United States Food and Drug Administration (FDA) for treatment of moderate to severe Alzheimer’s Dementia in adults. Treatment with immediate-release (IR) memantine—a low-to-moderate affinity, uncompetitive NMDA receptor antagonist—has been shown to improve both communication and social interactions in several trials conducted in individuals with ASD and pervasive developmental disorder not-otherwise specified (PDD-NOS) (Chez et al., 2007; Ghaleiha et al., 2013; Owley et al., 2006). Participants from both MEM-MD-91 and MEM-MD-68 were then eligible to enroll in MEM-MD-69, an open-label extension study to evaluate the long-term (up to 48 weeks) safety and tolerability of memantine-ER for ASD. And actually, its not bad advice if the child does not have ADHD. The baseline for each MEM-MD-69 efficacy parameter was baseline of the first lead-in study. One of the successes of these phase 2 trials was the recruitment of a very wide and diverse study population using a broad array of recruitment strategies (Spera et al., 2014); however, the publicity surrounding this program may have contributed to unrealistic expectations. The secondary endpoint, time-to-first LTR, was analyzed using Kaplan–Meier estimates; between-group comparisons for time-to-first LTR were performed using the log-rank test stratified by ASD subtype; hazard ratio and 95% confidence interval (CI) were estimated using a Cox model with treatment group and ASD subtypes as explanatory variables. Simply select your manager software from the list below and click on download. At the end of the 50-week study, treatment with memantine-ER conferred greater numerical mean improvements from baseline on the ABC subscales, the CCC-2 subscales, the CGI-S, and the CGI-I (Supplemental Material 3). Contact us if you experience any difficulty logging in. The drug comparisons information provided does not cover every potential use, warning, drug interaction, side effect, or adverse or allergic reaction. If you or your child take too much Adderall or overdoses, call your doctor or. A total of 868 participants had ⩾1 post-visit SRS total raw score and were included in the intention-to-treat (ITT) population (Figure 1); 765 (84.7%) completed the trial. Memantine, a drug used for the treatment of dementia, may help improve impaired executive function in adults with ADHD when used with standard stimulant therapy. AEs leading to premature discontinuation occurred in 60 (6.6%) participants, with a slightly higher percentage among those with autistic disorder (7.8%) than with Asperger’s disorder (4.4%) or PDD-NOS (4.4%). The SRS has been used as a primary measure of response to intervention in several other clinical trials (Aman et al., 2016; Constantino et al., 2003; Parker et al., 2017; Yatawara, Einfeld, Hickie, Davenport, & Guastella, 2016). Access to society journal content varies across our titles. Memantine was reported to be similar to methylphenidate in its ability to decrease symptoms of ADHD. After screening procedures, memantine is prescribed in randomized, double-blind fashion (equal chance of medication or placebo) … In PDD-NOS participants, the proportions of participants experiencing LTR were comparable between dose groups (Table 2). J Child Adolesc Psychopharmacol 2016. Baseline demographics were similar between ASD subtypes (Supplemental Material 1). The maximum daily dosage of memantine allowed in each group was 15, 9, 6, and 3 mg/day in groups A, B, C, and D, respectively. Common Questions and Answers about Memantine adhd. For instance, including a requirement that participant scores revert to baseline prior to the first dose of double-blind drug, or that a ⩾50% reduction in SRS improvement must occur, could add to the sensitivity of the LTR criterion. Create a link to share a read only version of this article with your colleagues and friends. the last available measurement before the first dose of study medication). At week 12, no clinically meaningful changes from baseline were observed between treatment groups on the additional efficacy variables, CGI-I and CGI-S, ABC-C, or SRS subscales and SRS total raw score.