“I know everybody here”

Hyperfamiliarity for unknown faces, a delusion of misidentification, is a rare disorder.

We present a 67-year-old female admitted with worsening cognitive impairment and poor self-care associated with parkinsonian symptoms of one-year duration. During evaluation, she was noted to relate to strangers with familiar gestures like people she already knew causing distress for family and care givers.

Workup revealed significant cognitive impairment, MOCA of 9/30 and neuroimaging showing diffuse temporal lobe volume loss predominantly on the left.

Assessment was Lewy body dementia with hyperfamiliarity for unknown faces.

This rare presentation reflects the need for detailed examination and workup during evaluation.

Report the efficacy of open-label amphetamine extended-release oral suspension (AMPH EROS) for the treatment of children with ADHD.

AMPH EROS has a 1-hr onset of effect and a duration of action of 13hours and was approved by FDA for treatment of ADHD in children aged 6–17 years based on a double-blind, placebo-controlled efficacy and safety study in children aged 6–12 years with ADHD. A significant treatment difference in change from pre-dose SKAMP-combined score was observed at the primary endpoint of 4hours post-dose (p<0.0001) and each post-dose time point assessed (1, 2, 4, 6, 8, 10, 12, 13hours).

Data reported here are from the 5-week, open-label dose optimization period. These efficacy data support the primary endpoint result.

Males and females aged 6 to 12 years with ADHD enrolled and began open-label treatment with 2.5 mg or 5mg/day of AMPH EROS titrated in 2.5–10mg/day increments until optimal dose (maximum 20mg/day). Doses could be decreased for tolerability. Subjects took morning AMPH EROS for 5weeks. Other efficacy outcomes during the open-label dose optimization phase: ADHD-RS (ADHD-Rating Scale), CGI-S (Clinical Global Impression of Severity), CGI-I (CGI-of Improvement) and CPRS (Conners’ Parent Rating Scale). All subjects were assessed for safety.

For the ITT population (n=99): treatment with AMPH EROS was associated with a mean change in ADHD-RS-IV (baseline to end of the open-label dose optimization; week 6) of 28.2 (±9.03) (Baseline score = 41.3±7.95). 90.9% of subjects had a change from baseline to open-label week 6 of ≥50% in the ADHD-RS-IV total score and were defined as responders. The CGI-S scores decreased continuously from baseline, with a high 4.8 at baseline to a low of 2.0 at open-label week 6. The percentage of subjects classified as moderately ill or greater correspondingly decreased from 97% at Baseline to 1% at open-label week 6. The decrease in the CGI-I over the study was similar to the change in CGI-S scores. CPRS for most categories decreased continuously from Baseline to open-label week 6. Mean change from baseline to open-label week 6 on the CPRS inattention T-score subscale was –25.3 (±14.38) and –24.4 (±13.87).

Adverse events (>5%) reported during dose optimization were decreased appetite, insomnia, affect lability, upper abdominal pain, mood swings and headache.

AMPH EROS was effective in reducing symptoms of ADHD in this open-label dose optimization. The AE profile of AMPH EROS was consistent with those of other amphetamine products.

Funding Acknowledgements: This work was funded by Tris Pharma, Inc.

To determine the efficacy and safety of amphetamine extended-release oral suspension (AMPH EROS) in the treatment of attention-deficit/hyperactivity disorder (ADHD) compared with placebo in a dose-optimized, randomized, double-blind study.

The efficacy of AMPH EROS was evaluated in a laboratory classroom study conducted in 108 pediatric patients (aged 6–12 years) with ADHD. The study began with an open-label dose optimization (5weeks) with an initial AMPH EROS dose of 2.5 or 5mg once daily in the morning. The dose could be titrated every 4–7 days in increments of 2.5–10mg until an optimal dose or the maximum dose of 20mg/day was reached. Subjects were required to tolerate a minimal dose of 10mg/day. Subjects then entered a 1-week randomized, double-blind treatment phase with the individually optimized dose or placebo. At the end of the week, raters evaluated the attention and behavior of the subjects in a laboratory classroom using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP-C) rating scale. SKAMP-C is a 13-item teacher-rated scale that assesses manifestations of ADHD in a classroom setting.

The primary efficacy endpoint was change from pre-dose in the SKAMP-C score at 4hours post dose. The key secondary endpoint efficacy parameters were onset and duration of clinical effect. The change scores from pre-dose SKAMP-C scores at post dose time points (1, 2, 6, 8, 10, 12 and 13hours) were used to evaluate the key secondary efficacy endpoints.

More boys (68.7%) than girls participated in the study. The study population was 55.6% white, most patients had inattentive or combined type ADHD presentations. The primary efficacy endpoint, the change from pre-dose SKAMP-C score at 4hours post dose was statistically significantly improved (p<0.0001) compared with placebo. Each of the secondary efficacy endpoints were also significantly improved (p<0.0001 at each time point) compared with placebo. Adverse events reported (frequency >5%) reported during the dose optimization phase were decreased appetite, insomnia, affect lability, upper abdominal pain, mood swings, and headache.

AMPH EROS was effective in reducing symptoms or ADHD from 1 to 13hours after dosing. Adverse events reported were consistent with those of other amphetamine products.

Funding Acknowledgements: This study was supported by Tris Pharma, Inc.

Bariatric surgery outcomes are variable, often with suboptimal weight loss and/or weight relapse. Smartphone coaching applications offer a potential window of affecting behavioral change to improve outcomes in a widespread and cost-effective way, but clinical efficacy is unknown. In phase I of this pilot study, we investigated effects of pre-surgical treatment with a mobile coaching platform Noom Coach for Bariatric Health.

Forty adult candidates (82.5% female) for bariatric surgery were recruited for pilot randomized controlled trial (Noom Bariatric Health vs. Standard Care). All participants’ dietary intake was assessed initially and after 8weeks of intervention, with the 24-hour dietary recall (ASA24) to analyze food intake. Paired t-tests were used to compare within group changes in dietary parameters. Independent t-tests were used to assess inter-group differences at the end of treatment.

Post intervention, both Noom and Control groups consumed numerically less total calories, empty calories, fat, and carbohydrates compared to their baseline. Reduction in empty calorie consumption was significant only in Noom (t=2.39, p=0.04, Cohen’s d=0.96) and not in Control (t=0.89, p=0.40, Cohen’s d=0.30). Both total kcal and total fat intake showed larger numerical reductions within Noom (kcal,fat: t=1.94,2.07; p=0.08,0.07; Cohen’s d=1.03,1.06) compared to reductions seen within Control (kcal,fat; t=0.41,0.48; p=0.69,0.64; Cohen’s d=0.14,0.16). There were no other significant changes in macronutrients and micronutrients within groups. At the end of treatment, Noom compared to Control groups had significantly lower percentage fat intake (t=3.02, p=0.008, Cohen’s d=1.42) without initial difference at screening (t=1.12, p=0.27, Cohen’s d=0.36).

Though limited due to small sample size, preliminary results appear promising that mobile coachingintervention may have beneficial effects on diet pre-bariatric surgery. We will discuss the impact of these findings on potential post-surgery outcomes.

Funding Acknowledgements: NIH R44DK116370, Mount Sinai Hospital

The objective of the study is to evaluate the differences in health outcomes as well as treatment satisfaction and functionality, focusing particularly in cognitive deficits and perceived disability among stable psychotic patients with therapeutic adherence treated with oral antipsychotics (OA) vs Aripiprazole Long Acting Inyectable (A-LAI).

Naturalistic study, descriptive and transversal. Inclusion criteria: Schizophrenia; 18-65 years old; CGI≤3; treatment OA or A-LAI; no changes antipsychotic therapy in last 3months. Sociodemographic and clinical variables were recorded using self-applied scales (TSQM;EQ-5;SDI;PDQ) and heteroaplied (PSP;CGI;UKU). A mirror analysis was performed in the A-LAI group comparing number of psychiatric drugs and antipsychotic used, previous admissions and emergency care visits.

50 patients (25 OA, 25 A-LAI), 62% male, age 43,9±11,1, psychotic illness evolution 15,9±9,9. In comparison with OA, A-LAI patients present greater functionality scores (PSP) 75±11,5 vs 61,8,±10,5 (p.001) and better results in quality of life (EQ-5D), both quantitatively, 69±18,6 vs 48,3±22,1 (p.005), and qualitatively (particularly in everyday tasks, OR 0,15 (p.009), and better health during the last year OR 0,16 (p.011). Additionally A-LAI patients showed less disability compared to OA, particularly in work areas (4,7 vs 6,8,p.017), social life (4,5 vs 6,6,p.006), overall disability (13 vs 18,p.022) and perceived stress (4,2 vs 6,2,p.020). Perceived cognitive deficits were lower in the A-LAI group, particularly in attention and concentration. There were significant differences in weight gained OR 0,22 (p.082) and sexual disfunction OR 0,078 (p.000) in favor of A-LAI. Prolactin levels are higher for the OA group, 41,7±30,8 vs 8,6±11,67ng/ml (p.003). Treatment satisfaction (TSQM) was significantly higher in A-LAI patients in all 4 dimensions. The factor that most influences the improvement in the functionality is the treatment with A-LAI instead of OA (–10,9±4,1,p.0117). A-LAI patients required a lower number of psychiatric drugs than OA. In A-LAI patients group was observed a statistical significant difference in the number of hospitalizations (1,8 vs 0,08,p.002), the number of admission days to the hospital (45,4 vs 1,5,p.010) and the number of emergency care needed (3,96 vs 0,6,p.000); furthermore, the number of antipsychotics was significantly reduced (2±1,3 vs 0,2±0,4) as well as the number of overall psychotic drugs (4,5±2,1 vs 2,2±1,4).

According to the data from our study patients with schizophrenia that are treated with A-LAI show better results in quality of life, functionality, less perceived disability and cognitive deficits compare to those that received OA, as well as more levels of treatment satisfaction. Tolerance of A-LAI has been better than OA, particularly in the sexual and weight areas, being prolactin levels also lower. The change to A-LAI has allowed a reduced use of health resources.

Cats may respond to seizures with a threat response (Strong, 1999). Detailed description of this for seizures or pseudoseizures has not heretofore been described.

Case study: A 29-year-old right handed female, two years prior to presentation, developed onset of seizures which last approximately one minute, almost on a daily basis. These are associated with shortness of breath and postictal blurred vision. During these epoch, she would experience temporary amnesia; a feeling as if she had lost a couple years of memory which gradually returned within an hour. Pain and stress would precipitate a seizure. There were two different types of seizures. The first type was with an aura of white visual entopias in the center of her visual field without postictal amnesia. The second type is without aura, but there is amnesia for the event. In neither type would she bite her tongue nor manifest urinary or fecal incontinence. Just preceding either type of seizures, her cat, would uncharacteristically meow, saunter over to her, and nudge her head against her legs or scratch her with her front paws. In response to this, the patient would move as fast as she could to a safe place where she would be cushioned if she were to fall. Less than a minute after the cat would warn her, a seizure would manifest. During this event the cat would meow and lay beside her “as if guarding me” until the seizure would resolve. The cat has never displayed these behaviors unless a seizure was eminent. She admitted to daily panic attacks which the cat appeared to ignore.

Abnormalities in physical examinations: General: 1+ bilateral pedal edema. Neurological examination: Mental status examination: Digit span: 7 forward and 2 backwards. Able to spell the word “world” forwards but not backwards. (CN) examination: CN III, VI and IV: Right lateral rectus weakness. Reflexes: bilateral 3+ brachioradialis and quadriceps femoris. Absent ankle jerk. Positive jaw jerk with clonus. Bilateral positive Hoffman’s reflexes. Neuropsychiatric testing: Clock drawing test: 3 (abnormal). Go-No-Go Test: 6/6 (normal). 72-hour EEG normal.

Olfactory emanations occur (Brown, 2011) several hours prior to seizures (Litt, 2009; Rajna, 1997) which the feline may be sensitive due to its superior olfactory ability. The cat’s comportment may have induced anxiety in the patient, which then may have precipitated the seizure. The animal thus may be an epileptogenic animal rather than a warning animal. The cat may detect changes in emotion, which predicts the pseudoseizures. On the other hand, the cat may have been acting as an anxiogenic agent, precipitating a pseudoseizure. There may have been a misattribution error, such that she recalled the cat in a position of warning seizures but did not recall when the cat did not warn the seizures. Further investigation in the use of alarm cats as warning for imminent seizures is warranted.

Exacerbation of Multiple Sclerosis (MS) symptoms prior to weather change has not heretofore been described.

Case Study: A 60 year old right handed female with lifelong anxiety and four years of depression presented with a 20 year history of MS manifested by bilateral lower extremity pain and weakness and urinary incontinence. Since the onset, she observed that approaching storms or weather changes cause her symptoms to worsen. This manifests one day prior to the meteorological shifts of rain or snow. This occurs whether she is at home or on vacation and unlike the weatherman, “she is never wrong.” The aggravation of symptomatology would consist of worsening leg pain and weakness of both lower extremities so that her functional status changes from using a cane to a wheelchair. These symptoms begin one day prior to the storm and gradually worsen to the point of maximum intensity as the storm arrives. The baseline pain is usually 5/10 in severity but with the storm it increases to 8/10. The pain, which progressively worsens as the storm advances, is a vice-like numbness in her shins and spasm in her legs. The pain and weakness will persist for as long as the storm lasts. The pain diminishes and the motor symptoms improve six hours after the storm is over. She can differentiate approaching snow or rain such that snow causes more intense symptoms. She denies change in symptomatology on airplanes or when she is present at high altitude such as Las Vegas or Colorado. She also affirms that her symptoms are worse when she is in a hot tub and better in a cold-water bath. She reports that there is a family history of similar ability to predict the weather in a cousin and nephew, both who also suffer from MS.

Abnormalities in Neurological Examination: BP 159/115. Pulse 100. Mental Status Examination: disheveled. Depressed mood with congruent affect. Short-term memory: 5 digits forwards, 2 digits backwards. Recent memory: able to recall none of 4 objects in 3minutes without improvement with reinforcement. Unable to interpret similarities or proverbs. Poor ability to calculate. Reflexes: 3+ bilateral lower extremities. Clock Drawing Test: 1 (abnormal).

Uhthoff’s phenomena (hot bath test) is well described in MS (Humm, 2004), however the worsening of symptoms prior to weather change has not been reported. Possible mechanisms include meteorological induced anxiety and depression with associated exacerbation (Ackerman, 1998). Other possible mechanisms include misattribution, selective recall, or a misreporting due to psychological needs for acceptance by examiner, similar to the Hawthorne effect (observer effect) (Adair, 1984). With the approaching storms there could be a change in internal temperature, which then preferentially affects areas of demyelination (Kudo, 2014). It is worth querying those with epoch associated neurological disorders as to linkage with meteorological events.

Present a case of dronabinol-induced hypomania.

Dronabinol is a synthetic derivative of cannabis that is commonly prescribed for chemotherapy-induced nausea and vomiting or cachexia due to HIV/AIDS. The safety in those with bipolar disorder warrants further investigation as previous studies suggest that the use of cannabis may be associated with exacerbation of manic symptoms. The risk of developing manic symptoms in patients with bipolar disorder who use dronabinol is largely unknown. Clinical Case: A 55-year-old Caucasian male, following with psychiatry since July of 2016 for substance use disorder (alcohol, cocaine and cannabis), bipolar I disorder, generalized anxiety, PTSD, and intermittent sleep disturbances, was prescribed dronabinol 2.5mg twice daily on 5/19/17 to treat wasting syndrome and significant weight loss due to underlying HIV. He has been abstinent from alcohol, tobacco, and illicit substances for more than a year. The patient’s relevant medication list includes: bupropion XL 150mg daily, quetiapine 300mg daily at bedtime, and trazodone 50–100mg at bedtime. At psychiatrist visit on 7/10/17, his bipolar disorder was noted to be stable. But, after his dose of dronabinol was increased on 7/21/17 to 5mg twice daily, the patient presented to psychiatrist on 8/1/2017 in a state of hypomania, with symptoms including: increased interest in sex, insomnia and increased animation. His judgment and impulse control were slightly impaired. Excluding the dronabinol dose increase, no other medication changes had taken place and the patient was not using alcohol or other substances. Quetiapine was discontinued and olanzapine 10mg at bedtime was started. Bupropion was discontinued, trazodone was tapered off, and dronabinol was discontinued. Upon follow up within a month, our patient’s hypomania symptoms resolved. He was also gaining weight with the olanzapine and reported improved sleep. He was continued on olanzapine 10mg at bedtime and continued off the trazodone, bupropion and dronabinol. He continues to remain abstinent from alcohol and illicit drugs.

The underlying mechanism of dronabinol-induced manic symptoms in those with bipolar disorder remains unclear but may involve dopamine. Sensitization of the dopaminergic system by THC is thought to be associated with the development of manic symptoms in those that use cannabis. THC is associated with increased dopaminergic cell firing, dopamine synthesis, and dopamine release when used acutely.

Other medications associated with causing manic symptoms include bupropion and trazodone, as relevant to our case. However, our patient was stable on these medications before the addition of dronabinol. Thus, it is reasonable to conclude that the dronabinol likely caused our patient’s hypomania symptoms.

This case emphasizes the need to evaluate mental health conditions before prescribing cannabis derivatives such as dronabinol.