“David was a key contact at our client company on a number of complex CNS trials. He demonstrated an exceptional ability to establish a collaborative working relationship with all members of the CRO and internal team, such that members almost forgot who worked for which company. Complex decisions were made having valued and weighed the input of all. David is rightly highly respected in the CNS field, and has both great wisdom gathered from his vast experience, and the ability to innovate where necessary.”
David Hough
Morrisville, Pennsylvania, United States
3K followers
500 connections
About
Neuroscience Clinical Drug Development
Psychiatry
Mood…
Activity
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So proud of my incredible team to achieve this critical milestone! With relentless effort, we are advancing science and treatment landscape for…
So proud of my incredible team to achieve this critical milestone! With relentless effort, we are advancing science and treatment landscape for…
Liked by David Hough
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I am looking forward to delivering the keynote address at the upcoming New Therapeutic Approaches in Translational Mental Health Conference, taking…
I am looking forward to delivering the keynote address at the upcoming New Therapeutic Approaches in Translational Mental Health Conference, taking…
Liked by David Hough
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I am so grateful for the Army's Commitment to California!
I am so grateful for the Army's Commitment to California!
Liked by David Hough
Experience
Education
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Walter Reed Army Institute of Research (WRAIR)
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2-year research fellowship in clinical pharmacology with both didactic and practical course work. A research project focused on appropriate prescription of psychotropics in the elderly nursing home population
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Publications
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Benefit–Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment‐Resistant Depression
Clinical Pharmacology and Therapeutics
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Patient preferences for ketamine-based antidepressant treatments in treatment-resistant depression: Results from a clinical trial and panel
Neurology, Psychiatry, and Brain Research
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Efficacy and safety of esketamine nasal spray plus an oral antidepressant in elderly patients with treatment-resistant depression
American Journal of Geriatric Psychiatry
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Efficacy and safety of fixed-dose esketamine nasal spray combined with a new oral antidepressant in treatment-resistant depression: results of a randomized, double-blind, active-controlled study (TRANSFORM-1)
International Journal of Neuropsychopharmacology
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Randomized, Double-Blind Study of Fixed-Dose Intranasal Esketamine Plus Oral Antidepressant vs. Active Control in Treatment-Resistant Depression
Journal of Affective Disorders
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Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial
JAMA Psychiatry
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Efficacy and safety of flexibly dosed esketamine nasal spray combined with a newly initiated oral antidepressant in treatment-resistant depression: a randomized double-blind active-controlled study
American Journal of Psychiatry
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POST HOC ANALYSES OF ESKETAMINE NASAL SPRAY PLUS AN ORAL ANTIDEPRESSANT IN ELDERLY PATIENTS WITH TREATMENT-RESISTANT DEPRESSION
American Journal of Geriatric Psychiatry
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Efficacy and safety of paliperidone palmitate 3-month versus 1-month formulation in patients with schizophrenia: comparison between European and non-European population
Neuropsychiatric Disease and Treatment
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Esketamine nasal spray combined with an oral antidepressant for relapse prevention in treatment-resistant depression: results of a double-blind, randomized withdrawal, multicenter study (Sustain-1)
European Neuropsychopharmacology
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Long-term safety of esketamine nasal spray plus oral antidepressant in patients with treatment-resistant depression: SUSTAIN-2 phase 3 study
European Neuropsychopharmacology
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Randomized, double-blind study of flexibly-dosed intranasal esketamine plus oral antidepressant vs. active control in treatment-resistant depression
European Neuropsychopharmacology
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Paliperidone Palmitate 3-Monthly Versus 1-Monthly Injectable in Patients With Schizophrenia With or Without Prior Exposure to Oral Risperidone or Paliperidone: A Post Hoc, Subgroup Analysis
Clinical Drug Investigation
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Relapse after antipsychotic discontinuation in schizophrenia as a withdrawal phenomenon vs illness recurrence: a post hoc analysis of a randomized placebo-controlled study
The Journal of Clinical Psychiatry
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Interpretation of Change In Patient-Reported Outcomes in Treatment-Resistant Depression
Value in Health
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Efficacy and safety of intranasal esketamine for the rapid reduction of symptoms of depression and suicidality in patients at imminent risk for suicide: results of a double-blind, randomized, placebo-controlled study
American Journal of Psychiatry
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Paliperidone Palmitate 3-Monthly Versus 1-Monthly Injectable in Patients With Schizophrenia With or Without Prior Exposure to Oral Risperidone or Paliperidone: A Post Hoc, Subgroup Analysis
Clin Drug Investig
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Time to onset and time to resolution of extrapyramidal symptoms in patients with exacerbated schizophrenia treated with 3-monthly vs once-monthly paliperidone palmitate
Neuropsychiatric Disease and Treatment
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Paliperidone palmitate 3-month treatment results in symptomatic remission in patients with schizophrenia: a randomized, multicenter, double-blind, and noninferiority study
International clinical psychopharmacology
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Evaluation of Potentially Prolactin-Related Adverse Events and Sexual Maturation in Adolescents with Schizophrenia Treated with Paliperidone Extended-Release (ER) for 2 Years: A Post Hoc Analysis of an Open-Label Multicenter Study
CNS Drugs
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SWITCHING SCENARIOS FOR PALIPERIDONE PALMITATE 3-MONTH FORMULATION IN SCHIZOPHRENIA: A POPULATION PHARMACOKINETIC SIMULATION-BASED EVALUATION
AUSTRALIAN AND NEW ZEALAND JOURNAL OF PSYCHIATRY
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Paliperidone palmitate: Japanese postmarketing mortality results in patients with schizophrenia
Current medical research and opinion
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Baseline characteristics and treatment-emergent risk factors associated with cerebrovascular event and death with risperidone in dementia patients
British Journal of Psychiatry
Only anti-inflammatory medications increased mortality risk with risperidone. The reduced risks of CVAE in patients with comorbid depression and delusions, and of mortality with depression, may have clinical implications when weighing the benefits and risks of treatment with risperidone in patients with dementia.
Other authorsSee publication -
Efficacy and safety of paliperidone palmitate 3-monthly versus 1-monthly formulation in Asian patients with schizophrenia: Subgroup analysis of a randomized, double-blind, noninferiority study
International Journal of Neuropsychopharmacology
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Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia
Journal of the American Medical Association - Psychiatry
Patients received once-monthly doses of the 1-month formulation of paliperidone palmitate (50, 75, 100, or 150 mg eq) during the transition phase, followed by a single dose of the 3-month formulation (3.5 times the stabilized dose of once-monthly paliperidone palmitate) during the maintenance phase. Stabilized patients were randomized to receive either a fixed dose of 3-month paliperidone palmitate (175, 263, 350, or 525 mg eq) or placebo once every 3 months during the DB phase.
Results…Patients received once-monthly doses of the 1-month formulation of paliperidone palmitate (50, 75, 100, or 150 mg eq) during the transition phase, followed by a single dose of the 3-month formulation (3.5 times the stabilized dose of once-monthly paliperidone palmitate) during the maintenance phase. Stabilized patients were randomized to receive either a fixed dose of 3-month paliperidone palmitate (175, 263, 350, or 525 mg eq) or placebo once every 3 months during the DB phase.
Results In the interim analysis, time to first relapse was significantly different in favor of the paliperidone palmitate group vs the placebo group (hazard ratio = 3.45; 95% CI, 1.73-6.88; P < .001); median time to relapse was 274 days for placebo but not estimable for 3-month paliperidone palmitate. An independent data monitoring committee recommended early study termination due to efficacy. In the DB phase, 183 of 305 patients (62% with 3-month paliperidone palmitate; 58% with placebo) had at least 1 treatment-emergent adverse event; those noted more frequently in the group receiving paliperidone palmitate than in the placebo group were headache (9% vs 4%), weight increased (9% vs 3%), nasopharyngitis (6% vs 1%), and akathisia (4% vs 1%).
Conclusions: Compared with placebo, the 3-month formulation of paliperidone palmitate administered 4 times yearly significantly delayed time to relapse in patients with schizophrenia. The 3-month formulation was generally tolerable and has a safety profile consistent with other marketed paliperidone formulations. -
Pharmacokinetic profile after multiple deltoid or gluteal intramuscular injections of paliperidone palmitate in patients with schizophrenia
Clinical Pharmacology in Drug Development
Paliperidone palmitate (PP) is a once-monthly long-acting injectable antipsychotic approved for the treatment of schizophrenia in many countries. To evaluate the different injection site options, we compared the pharmacokinetic profile of paliperidone after multiple injections of PP 100 mg eq. (156 mg of PP, equivalent to 100 mg of paliperidone) on days 1, 8, 36 and 64 into the deltoid (n = 24) or gluteal muscle (n = 25) in patients with schizophrenia. After four injections in the…
Paliperidone palmitate (PP) is a once-monthly long-acting injectable antipsychotic approved for the treatment of schizophrenia in many countries. To evaluate the different injection site options, we compared the pharmacokinetic profile of paliperidone after multiple injections of PP 100 mg eq. (156 mg of PP, equivalent to 100 mg of paliperidone) on days 1, 8, 36 and 64 into the deltoid (n = 24) or gluteal muscle (n = 25) in patients with schizophrenia. After four injections in the deltoid-muscle, paliperidone exposure was higher for AUCτ and Cmax, compared with the gluteal-muscle (geometric mean AUCτ-based ratio: 120% [90% CI: 93.1-154.7%], and geometric mean Cmax-based ratio: 130% [90% CI: 100.6-168.9%]). The mean [SD] fluctuation index was higher, with a larger interpatient variability, after deltoid-injections (75.9% [30.9%]) than gluteal-injections (58.5% [14.3%]). The median tmax was similar for both sites. PP was generally tolerable in patients, with more favorable local-site tolerability for gluteal-injection. In conclusion, to achieve therapeutic-concentrations quickly, the first-two injections of PP are best administered into the deltoid-muscle, whereas thereafter maintenance-injections can be administered either in the deltoid or gluteal muscle.
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Effect of Parental Age on Treatment Response in Adolescents with Schizophrenia
Schizophrenia Research
Background: Advanced paternal age (APA) is associated with increased risk for schizophrenia, but its effect on treatment response has not been longitudinally studied.
Methods: Association of parental ages at the time of the child's birth with age of onset, initial symptom severity and treatment response (to placebo and three different weight-based doses of paliperidone ER) in adolescents with schizophrenia was assessed in a post-hoc analysis using data from a 6-week double-blind study, the…Background: Advanced paternal age (APA) is associated with increased risk for schizophrenia, but its effect on treatment response has not been longitudinally studied.
Methods: Association of parental ages at the time of the child's birth with age of onset, initial symptom severity and treatment response (to placebo and three different weight-based doses of paliperidone ER) in adolescents with schizophrenia was assessed in a post-hoc analysis using data from a 6-week double-blind study, the primary results of which are published (NCT00518323).
Results: The mean (SD) paternal age was 29.2 (6.2) years, range (16–50) and maternal age was 26.8 (5.7) years range (17–42) at childbirth for the 201 adolescents (ages 12–17 years) included in the analysis. While parental ages were uncorrelated with age of onset or initial symptom severity, both maternal and paternal ages showed significant effects on treatment response (p b 0.03) of all paliperidone ER arms versus placebo. Paternal age was significantly correlated to improvement in positive symptoms and maternal age significantly related to negative symptoms, although only paternal age remained significantly associated with the treatment response in analyses that included both parents' ages.
Conclusions: APAwas associatedwith greater treatment response to both paliperidone ER and placebo, but not to age of onset or initial symptom severity in adolescents with schizophrenia. The results support the contention that APA-related schizophrenia has distinct underpinnings from other cases. Further studies are required to explore the role of genetic and environmental factors, and their interactions, in treatment response in this complex disorder.Other authors -
Which Schizophrenia Subjects Relapse Despite Adherence to Long-acting Antipsychotic Therapy?
American College of Neuropsychopharmacology
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Risperidone Dosing in Children and Adolescents with Autistic Disorder: A Double-Blind, Placebo-Controlled Study
Journal of Autism and Developmental Disorders
Efficacy and safety of 2 risperidone doses were evaluated in children and adolescents with autism. Patients (N = 96; 5–17 years), received risperidone (low-dose: 0.125 mg/day [20 to\45 kg], 0.175 mg/day [[45 kg] or high-dose: 1.25 mg/day [20 to \45 kg], 1.75 mg/day [[45 kg]) or placebo. Mean baseline (range 27–29) to endpoint change in Aberrant Behavior Checklist-Irritability (primary endpoint) was significantly greater in the highdose—(-12.4 [6.5]; p\0.001), but not low-dose (-7.4
[8.1]; p…Efficacy and safety of 2 risperidone doses were evaluated in children and adolescents with autism. Patients (N = 96; 5–17 years), received risperidone (low-dose: 0.125 mg/day [20 to\45 kg], 0.175 mg/day [[45 kg] or high-dose: 1.25 mg/day [20 to \45 kg], 1.75 mg/day [[45 kg]) or placebo. Mean baseline (range 27–29) to endpoint change in Aberrant Behavior Checklist-Irritability (primary endpoint) was significantly greater in the highdose—(-12.4 [6.5]; p\0.001), but not low-dose (-7.4
[8.1]; p = 0.164) group, versus placebo (-3.5 [10.7]). Clinical Global Impressions-Severity and Children’s Yale- Brown Obsessive Compulsive Scale scores improved significantly only in the high-dose group, consistent withABC-I results. Somnolence, sedation and increased appetite occurred more frequently in high-versus low-dose groups.Other authors -
A one-year prospective study of the safety, tolerability and pharmacokinetics of the highest available dose of paliperidone palmitate in patients with schizophrenia
BMC Psychiatry
Coppola D, Liu Y, Gopal S, Remmerie B, Samtani M, Hough DW, Nuamah I, Sulaiman AH, Pandina G. A one-year prospective study of the safety, tolerability and pharmacokinetics of the highest available dose of paliperidone palmitate in patients with schizophrenia BMC Psychiatry 2012, 12:26
Other authorsSee publication -
A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia
International Journal of Neuropsychopharmacology
Fleischhacker, W.W., Gopal, S., Lane, R., Gassmann-Mayer, C., Lim, P., Hough, D., Remmerie, B., Eerdekens, M., A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia. Int J Neuropsychopharmacol. 2012; 15: 107-118.
Other authorsSee publication -
Prolongation of cardiac ventricular repolarization under paliperidone: how and how much?
J Cardiovasc Pharmacol. 2012. 59: 298-9.
Hough, D.W., Gopal, S., Coppola, D., Remmerie, B.M., Berwaerts, J., Nuamah, I.F., Sterkens, P.C., Xu, Y. Prolongation of cardiac ventricular repolarization under paliperidone: how and how much? J Cardiovasc Pharmacol. 2012. 59: 298-9
Other authors -
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Treatment response after relapse in a placebo-controlled maintenance trial in schizophrenia
Schizophrenia Research
Emsley, R., Nuamah I, Hough D, Gopal S., Treatment response after relapse in a placebo-controlled maintenance trial in schizophrenia, Schizophr. Res. (2012), doi:10.1016/j.schres.2012.02.030.
Other authorsSee publication -
A randomized, double-blind study of paliperidone extended-release in treatment of acute schizophrenia in adolescents
Biological Psychiatry
Singh J, Robb A, Vijapurkar U, Nuamah I. Hough D. A randomized, double-blind study of paliperidone extended-release in treatment of acute schizophrenia in adolescents. Biological Psychiatry 2011 Dec 15;70(12):1179-87
Other authorsSee publication -
Changes in Schizophrenia-related Health Care Resource Utilization Among Patients Receiving Paliperidone Palmitate: Results From a 52-week, Maintenance of Effect Clinical Tria
Current Medical Research and Opinion
Kozma CM, Slaton T, Dirani R, Gopal S, Hough D. Changes in Schizophrenia-related Health Care Resource Utilization Among Patients Receiving Paliperidone Palmitate: Results From a 52-week, Maintenance of Effect Clinical Trial. Current Medical Research and Opinion. 2011 Jun 27(8):1603-1611.
Other authorsSee publication -
A 52-week open-label study of the safety and tolerability of paliperidone palmitate in patients with schizophrenia
http://jop.sagepub.com/content/25/5/685.short
Gopal S, Vijapurkar U, Lim P, Morozova M, Eerdekens M, Hough D. A 52-week open-label study of the safety and tolerability of paliperidone palmitate in patients with schizophrenia. J Psychopharmacol 2011 May 25(5):685-697.
Other authorsSee publication -
A Post-hoc Comparison of Paliperidone Palmitate to Oral Risperidone During Initiation of Long-acting Risperidone Injection in Patients with Acute Schizophrenia
Innovations in Clinical Neuroscience
Gopal S, Pandina G, Lane R, Nuamah I, Remmerie B, Coppola D, Hough D. A Post-hoc Comparison of Paliperidone Palmitate to Oral Risperidone During Initiation of Long-acting Risperidone Injection in Patients with Acute Schizophrenia. Innovations in Clinical Neuroscience 2011;8(8):26-33
Other authorsSee publication -
Efficacy and Safety of Paliperidone Extended Release 1.5 mg/day A Double-blind, Placebo- and Active-Controlled, Study in the Treatment of Patients with Schizophrenia
Psychopharmacology Bulletin
Coppola D, Melkote R, Lannie C, Singh J, Nuamah I, Gopal S, Hough D, Palumbo J. Efficacy and Safety of Paliperidone Extended Release 1.5 mg/day A Double-blind, Placebo- and Active-Controlled, Study in the Treatment of Patients with Schizophrenia. Psychopharmacology Bulletin 2011;44(2):1-20.
Other authorsSee publication -
Number needed to treat and number needed to harm with paliperidone palmitate relative to long-acting haloperidol, bromperidol, and fluphenazine decanoate for treatment of patients with schizophrenia
Neuropsychiatric Disease and Treatment
Gopal S, Berwaerts J, Nuamah I, Akhras, K, Coppola D, Daly E, Hough D, Palumbo J. Number needed to treat and number needed to harm with paliperidone palmitate relative to long-acting haloperidol, bromperidol, and fluphenazine decanoate for treatment of patients with schizophrenia. Neuropsychiatr Dis Treat 2011;7:93-101. Epub 2011 Mar 8.
Other authorsSee publication -
Low-dose olanzapine for self-mutilation behavior in patients with borderline personality disorder.
Physicians Postgraduate Press
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Unilateral facial numbness and visual blurring associated with paroxetine discontinuation
Journal of Clinical Psychopharmacology
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A suicide prevention advisory group at an academic medical center
Military Medicine
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AN ASSESSMENT OF CRITERIA FOR INAPPROPRIATE PRESCRIBING OF PSYCHOTROPIC MEDICATIONS IN THE ELDERLY
CLINICAL PHARMACOLOGY & THERAPEUTICS
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Panic disorder in a patient taking oxaprozin.
American Journal of Psychiatry
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Benefit-Risk Assessment of Esketamine Nasal Spray versus Placebo in Treatment-Resistant Depression.
Clinical Pharmacology and Therapeutics
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French
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We remain steadfast in our commitment to working with the FDA to bring this potential new therapy to patients. Read our full announcement here:…
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