Still, Lipton saw NMDA receptors as a good target for treating autism … 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. Participants randomized to the full-dose arm received the same weight-based open-label memantine dose received in MEM-MD-91. If you have specific questions regarding a drug’s safety, side effects, usage, warnings, etc., you should contact your doctor or pharmacist, or refer to the individual drug monograph details found on the FDA.gov or RxList.com websites for more information. The e-mail addresses that you supply to use this service will not be used for any other purpose without your consent. If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. 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%). A ttention deficit hyperactivity disorder (ADHD) is the most commonly diagnosed psychiatric problem in children. Most TEAEs were mild to moderate in intensity. Before the conduct of any study procedure, participants provided written informed assent (when developmentally appropriate), and the study participant’s parent, legal guardian, or legally authorized representative provided voluntary and written informed consent (in compliance with 21 CFR Parts 50 and 312) and Health Insurance Portability and Accountability Act (HIPAA) authorization (United States). Memantine, an N-methyl-d-aspartate (NMDA) receptor antagonist, was titrated to a maximum dose of 10 mg BID in 34 adult subjects aged 18-55 who met DSM-IV criteria for ADHD or ADHD NOS on structured interview. MEM-MD-69 was carried out in full compliance with the guidelines of the IECs and national health authorities of Belgium, Canada, Colombia, Estonia, France, Hungary, Iceland, Italy, New Zealand, Poland, Republic of Korea, Serbia, South Africa, Spain, and Ukraine. 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. RxList.com assumes no responsibility for any healthcare administered to a person based on the information found on this site. 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. See additional information. Although many clinical trials in ASD and other neurodevelopmental disorders are unsuccessful for numerous reasons, the findings from such trials should neither be completely dismissed nor presumed to be invalid (Jeste & Geschwind, 2016). What Are Possible Side Effects of Namenda? . Two open label studies also reported positive effects in ADHD. Treatment emergent adverse events ⩾3% in any treatment group (safety population). 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. The email address and/or password entered does not match our records, please check and try again. Participants randomized to placebo were switched from their weight-based open-label memantine dose to placebo at randomization. Talk to your doctor if you or your child have side effects that are bothersome or do not go away. The most common TEAEs were irritability, vomiting, agitation, and anxiety (Table 3). Adderall should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. The drug comparison information found in this article does not contain any data from clinical trials with human participants or animals performed by any of the drug manufacturers comparing the drugs. Safety parameters were summarized by means of descriptive statistics for the safety population, defined as all randomized participants who received ⩾1 dose of double-blind treatment (MEM-MD-68) or ⩾1 dose of open-label memantine-ER (MEM-MD-91, MEM-MD-69). Doctors will also sometimes prescribe memantine to help reduce or better manage some of the symptoms commonly seen in ADHD. 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. redness or swelling of or around your eyes, or, slowing of growth (height and weight) in children, seizures, mainly in patients with a history of seizures, cold or allergy medicines that contain decongestants. Namenda is used off-label for ADHD. The ratings for CGI-I range from 1 (marked improvement) to 7 (marked worsening). Twenty-eight subjects completed 12 weeks exposure. A pilot open label prospective study of memantine monotherapy in adults with ADHD. 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. Serious side effects include: slowing of growth (height and weight) in children seizures, mainly in patients with a history of seizures eyesight changes or blurred vision Serotonin syndrome. To provide a sufficient number of responders for enrollment in MEM-MD-68, approximately 800–900 participants would be enrolled in MEM-MD-91. 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). 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. As participants in MEM-MD-68 had a very high response rate at the end of the open-label lead-in trial (all were confirmed responders), this enriched population may be particularly susceptible to placebo effects and/or high expectations among caregivers, suggesting a need for a higher threshold for the responder criterion or a larger change on the SRS (>10-point increase in score) to define LTR. Memantine has been effective in treating memory problems in Alzheimer Dementia, obsessive–compulsive disorder, autism disorder, and other psychological diseases. The vast majority of children and adults with ADHD also have trouble with executive functions, the cognitive and mental abilities that help people engage in goal-directed action. Similar percentages of participants with autistic disorder (83.3%), Asperger’s disorder (88.1%), and PDD-NOS (86.6%) completed the study. CDF: cumulative distribution function, SRS: social responsiveness scale. The large, mean improvements in SRS scores from baseline to end of open-label treatment (at levels that were three to four times the theorized clinically meaningful improvement level of 10 points) may be further evidence that caregivers had an expectation of success and falsely created treatment responders. Adderall may affect your or your child's ability to drive or do other dangerous activities. In open-label trial MEM-MD-69, 749 participants were screened and 747 received ⩾1 dose of study medication (safety population). Assessment of global functioning in adolescents with autism spectrum disorders: Utility of the ... Psychopharmacology of autism spectrum disorders: A selective review. 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). Keep a list of your medicines with you to show your doctor and pharmacist. A total of 17 participants discontinued due to an AE: aggression (0.5%), abnormal behavior (0.4%), anxiety (0.4%), irritability (0.3%), and weight increased (0.3%). Change from baseline to week 12 for each CCC–2 subscale (secondary endpoint) was performed using an analysis of covariance model with treatment group and ASD subtype as factors and baseline score as covariate, using the last observation carried-forward (LOCF) approach. If you have ADHD, you need to try this. See additional information. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. P2 is the P value for the treatment comparison between memantine reduced-dose and placebo based on log-rank test stratified by Autism Spectrum Disorder subtype. In the United States, approved pharmacological interventions for autism spectrum disorder (ASD) are limited to risperidone and aripiprazole, both of which are indicated by the US Food and Drug Administration (FDA) for the treatment of irritability associated with ASD (Janssen Pharmaceuticals, Inc., 2014; Otsuka Pharmaceutical Co., Ltd., 2016), but not for the core symptoms of impaired social communication and interaction, stereotyped behaviors, and restricted interests (Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), 2013). It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Figure 7. 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). In the double-blind study (MEM-MD-68), participants were randomized 1:1:1 to memantine-ER full-dose, memantine-ER reduced dose (to assess dose response per FDA request), or placebo. 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. There were no significant changes from baseline to week 12 on any CCC-2 subscale between the placebo and memantine treatment groups (LOCF). 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. Members of _ can log in with their society credentials below, Antonio Y Hardan, Robert L Hendren, Michael G Aman, Adelaide Robb, Raun D Melmed, Kristen A Andersen, Rachel Luchini, Rezwanur Rahman, Sanjida Ali, X Daniel Jia, Madhuja Mallick, Jordan E Lateiner, Robert H Palmer, and Stephen M Graham, This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (. The drug information provided is intended for reference only and should not be used as a substitute for medical advice. (, Owley, T., Salt, J., Guter, S., Grieve, A., Walton, L., Ayuyao, N., . 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. Indeed, these results suggest the need to perhaps refine the definition of LTR so that possible treatment effects would not be obscured. confirmed responder) were eligible to transition to randomized trial MEM-MD-68. .Hardan, A. Y. Compared with baseline, fewer participants had an overall CGI-S rating of severely ill (1.3% vs 7.8%), markedly ill (9.4% vs 32.0%), or moderately ill (37.9% vs 48.1%) at study end. As the manner in which ASD clinical trials are conducted has evolved over the years, the results from this trial program will hopefully inform future decisions when considering the design of large trials of pharmacotherapies in ASD individuals. Of 479 (92.6%) confirmed responders from lead-in study MEM-MD-91 who were randomized, 477 received ⩾1 dose of double-blind study medication, and 471 participants had ⩾1 post-baseline SRS total raw score assessment and were included in the ITT population (Figure 2). 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%). Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Three participants discontinued; of the three that continued, memantine was reduced only in the participant who experienced gastroenteritis. 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. 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). While there have been no major studies conducted, some doctors have reported phenomenal success prescribing it both in conjunction with, and in place of stimulants. Read More. You may also report negative side effects of prescription drugs to the FDA by visiting the FDA MedWatch website or calling 1-800-FDA-1088. 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). Following the 12-week double-blind study, participants were eligible to enroll in a long-term (48 week) safety and tolerability extension study (MEM-MD-67, conducted November 2009 through February 2013; NCT01999894) examining open-label memantine-ER (Aman et al., 2016). the site you are agreeing to our use of cookies. Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs. 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. DSM-IV-TR terminology in which autistic disorder, Asperger’s disorder, and PDD-NOS were defined separately from the current spectrum known as ASD).