Memantine and ADHD. Regardless of treatment group, approximately 33% of participants met LTR criterion by the first visit (~2 weeks; Figure 5). The proportion of participants diagnosed with autistic disorder was approximately two-thirds of the population with the remainder split nearly equally between Asperger’s disorder and PDD-NOS (Supplemental Material 1). 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. Each item is rated from 0 to 3 in a Likert-type response format with higher scores indicating greater social impairment. As pediatric patients are expected to gain weight during the course of development, study participants could be reassigned to the next higher weight group during the course of the study (per prespecified criteria) to maintain drug exposure levels that were considered therapeutically equivalent if a participant’s weight deviated significantly over time. Figure 5. As a result of early study termination, 582 participants discontinued (Figure 3) and thus full evaluations of efficacy outcomes were not performed. Like MEM-MD-57A and MEM-MD-67, memantine-ER was administered over a limited, weight-based dose range (3–15 mg/day). 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). Another study confirms that although “memantine was less effective than methylphenidate [Ritalin] in the treatment of attention deficit hyperactivity disorder, it may be considered as an alternative treatment.” 12 Mohammad Reza Mohammadi, et al. This is not a complete list of possible side effects. The objective of each trial and the details regarding study design, enrollment criteria, and efficacy and safety outcomes are described in Table 1. This product could help you, Accessing resources off campus can be a challenge. Such variability in baseline conditions has been previously recognized as possibly contributing to the uncertainty of the outcomes in these trials and other studies of neuropsychiatric disorders (Benedetti, Carlino, & Piedimonte, 2016). Figure 7. Adderall may harm others, and is against the law. In one recent randomized, double-blind, placebo-controlled study published by Ghaleiha et al. An independent Data and Safety Monitoring Board (DSMB) reviewed safety data at defined intervals throughout each study. Namenda may interact with cimetidine, nicotine, ranitidine, quinidine, sodium bicarbonate, antiviral medication, cold or cough medicine containing dextromethorphan, diuretics (water pills), medicine to treat glaucoma, or oral diabetes medicine containing metformin. 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). The ratings for each CGI-S evaluation range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Discovering effective interventions for child neurodevelopmental disorders remains an ambitious and important endeavor, as early intervention in both psychiatric and behavioral disorders (including ASD, attention deficit hyperactivity disorder (ADHD), depression, and anxiety) may alter long-term prognoses (Grabb & Gobburu, 2017). The study aims to examine the effects of treatment with memantine on ADHD symptoms. 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). 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). Overall, there were negligible differences between treatment groups in the cumulative percentage of participants achieving improvement in SRS total raw scores by study end; however, there appeared to be a trend toward smaller cumulative percentages of participants in the memantine full-dose group versus either the placebo or reduced-dose memantine groups in which a worsening of +10 to +20 points on SRS total score from baseline was observed (Figure 6). Yes, the little one could have ADHD. Findings from these three studies of memantine-ER in ASD participants are reported here. 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. After screening procedures, memantine is prescribed in randomized, double-blind fashion (equal chance of medication or placebo) … The statistically insignificant findings of the double-blind, placebo-controlled trial of memantine ER in ASD individuals presented here are no exception. 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. While the 10-point threshold was not based on empirically derived criteria for a minimal clinically important difference (MCID), the cutoff was recommended based on clinically meaningful observations (Dr John N Constantino, personal communication, October 2011) and was further discussed with the FDA. Chronic and episodic use of analgesics (nonnarcotic only), antiacne medications (topical only, excluding isotretinoin), antihistamines, topical antifungal agents, anti-inflammatory drugs (excepting indomethacin and systemic corticosteroids), antipsoriatic treatments (except acitretin), anxiolytics, H2 blockers/proton pump inhibitors (only if stable for at least 6 months prior to lead-in study), laxatives (if taken before lead-in study), migraine treatment, muscle relaxants, sedatives/hypnotics, steroids (topical, inhalant, intranasal), vitamins, and herbal remedies was allowed. 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). Sometimes the doses of other medicines will need to be adjusted while taking Adderall. You can be signed in via any or all of the methods shown below at the same time. If you or your child take too much Adderall or overdoses, call your doctor or. Having spent almost 40 years in the classroom. Any missing drug warnings or information does not in any way guarantee the safety, effectiveness, or the lack of adverse effects of any drug. 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. Memantine is a prescription drug. A total of 81 (10.8%) completed the study by the time of early termination (31 January 2014; see Studies and procedures). Doctors will also sometimes prescribe memantine to help reduce or better manage some of the symptoms commonly seen in 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). ITT: intention-to-treat, LTR: loss of therapeutic response. Adderall treatment may be stopped if a problem is found during these check-ups. Overall, 30.1% completed the study and 65.8% discontinued due to LTR (Supplemental Material 2). Future studies may consider possible instrument-specific effects and an MCID, as well as potential caregiver biases and expectations suggested by these results. The cumulative percentages of participants achieving a −10 to −80 point change from baseline in SRS total raw score at week 12 was slightly greater among those with Asperger’s disorder and PDD-NOS versus autistic disorder (Figure 4(a)). Children should have their height and weight checked often while taking Improves Focus and Helps with ADHD. 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. This site uses cookies. Figure 6. 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). Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. The baseline for each MEM-MD-69 efficacy parameter was baseline of the first lead-in study. Briefly, open-label memantine-ER was administered by weight in trials MEM-MED-91 and MEM-MD-69, and participants were divided into four weight groups: group A, ⩾60 kg; group B, 40–59 kg; group C, 20–39 kg; and group D, <20 kg. Mean improvements in SRS total raw scores two to three times the 10-point minimum used to confirm treatment responders were observed from baseline to the end of the study for the ITT population and for each ASD subtype; similar results were observed among confirmed responders at week 12 (Table 2). Both Namenda and Adderall may interact with sodium bicarbonate (Alka-Seltzer) or diuretics (water pills). Eight (1.1%) participants reported a total of 11 on-therapy SAEs (all n = 1): abdominal pain (periumbilical), abdominal pain (right lower quadrant), abnormal behavior, appendicitis, dehydration, dysphoria, foreign body, homicidal ideation, rectal prolapse, suicidal ideation, and vomiting. 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. 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). Conducting clinical trials in children is fraught with many operational, physiological, and ethical challenges (Kern, 2009). Memantine has been effective in treating memory problems in Alzheimer Dementia, obsessive–compulsive disorder, autism disorder, and other psychological diseases. MEM-MD-69 exploratory analyses revealed mean standard deviation improvement in Social Responsiveness Scale total raw score of 32.4 (26.4) from baseline of the first lead-in study. 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. The ABC-C is a 58-item questionnaire with five subsections to assess behavioral symptoms of irritability, social withdrawal, stereotypy, hyperactivity/noncompliance, and inappropriate/repetitive speech. (, Constantino, J. N., Davis, S. A., Todd, R. D., Schindler, M. K., Gross, M. M., Brophy, S. L., Reich, W. (, Findling, R. L., McNamara, N. K., Stansbrey, R. J., Maxhimer, R., Periclou, A., Mann, A., Graham, S. M. (, Ghaleiha, A., Asadabadi, M., Mohammadi, M. R., Maxhimer, R., Periclou, A., Mann, A., Graham, S. M. (, Masi, A., Lampit, A., Glozier, N., Hickie, I. 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. Approximately 75% of all participants achieved ⩾10-point improvement in SRS total raw score (Figure 4(a)). 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. The minimum recommended interval between dose increases is one week. Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. P1 is the P value for the treatment comparison between memantine full-dose and placebo based on log-rank test stratified by Autism Spectrum Disorder subtype. Mean SRS total raw score at visit 1 (extension baseline) was 86.7 ± 29.5 (safety population), which was approximately 21 points lower than baseline of the lead-in study (108.4 ± 24.5). Ask your doctor or pharmacist for more information. It is approved to treat moderate to severe Alzheimer's type dementia. Based on the SRS manual, the SD of parent report for the entire standardization sample (N = 1011) was 24.6 with a mean of 31.2 and an SEM of 6.29. Participants are referred to as they were classified at the time the studies were conducted (i.e. Please check you selected the correct society from the list and entered the user name and password you use to log in to your society website. Three participants (all with Asperger’s disorder) experienced a behavior-related SAE: dysphoria (treatment related), homicidal and suicidal ideation (not treatment related), and abnormal behavior (not treatment related). 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. (7) This included improved ability to focus and concentrate as well as a … 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. From time to time, your doctor may stop Adderall treatment for a while to check ADHD symptoms. Namenda and Namzaric belong to different drug classes. No new safety concerns were evident. Namenda and Adderall belong to different drug classes. Items were rated by an informant and based on behavior observed over the prior 2-week period with higher scores indicating greater impairment. Premier, Inc. provided Interactive Web Response System (IWRS) services for randomization and investigational-product dispensing for all countries. FundingThe author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Funding for these studies was provided by Forest Research Institute (Jersey City, NJ), the sponsor at the time the studies were conducted. Adderall. Adderall tablets are usually taken two to three times a day. 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. If the address matches an existing account you will receive an email with instructions to reset your password Adderall should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. (, Spera, A., Atwell, R. S., Marquez, M. L., Graham, S. M. (, Werry, J. S., Sprague, R. L., Cohen, M. N. (, Yatawara, C. J., Einfeld, S. L., Hickie, I. Memantine was largely well-tolerated and associated with improvement in ADHD symptoms and neuropsychological performance. Consult your doctor before breastfeeding. Adderall is also used in the treatment of a sleep disorder called narcolepsy. In MEM-MD-68, participants must have had ⩾12 weeks of open-label treatment and met the confirmed responder criterion in study MEM-MD-91 to participate in this 12-week, randomized, double-blind, placebo-controlled withdrawal study. Memantine adhd. One participant in the placebo group (Asperger’s disorder) discontinued the study due to an AE (irritability), and one participant in the reduced-memantine group reported an on-therapy SAE (furuncle of the nasal bridge) that was unrelated to study drug. . This sample size was considered convincingly large to detect a clinically meaningful difference in LTR, as agreed upon with the FDA (8 May 2013). Dose increases for concomitant medications were prohibited during the study, but dose reductions were allowed upon consultation with the Sponsor Study Physician. In the chapter about mediations, he talks about the possibility of using the amantadine to treat ADHD. Randomized studies are indicated to confirm whether memantine is a novel therapy for ADHD across the lifespan. To provide a sufficient number of responders for enrollment in MEM-MD-68, approximately 800–900 participants would be enrolled in MEM-MD-91. Memantine was reported to be similar to methylphenidate in its ability to decrease symptoms of ADHD. 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). 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. 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 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. But, i have had kids in the classroom who have ADHD and their brother or sister did not. 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. All drug information provided on RxList.com is sourced directly from drug monographs published by the U.S. Food and Drug Administration (FDA). 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. The total of 70 items (seven per subscale) is rated from 0 to 3 with higher scores indicating greater impairment. The e-mail addresses that you supply to use this service will not be used for any other purpose without your consent. Namenda is an orally active NMDA receptor antagonist and Adderall is an amphetamine. 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. Most TEAEs were mild to moderate in intensity. Simply select your manager software from the list below and click on download. Still, Lipton saw NMDA receptors as a good target for treating autism … . 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