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Publications (9)26.64 Total impact

  • Nicholas A DeMartinis, Jayesh Kamath, Andrew Winokur
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    ABSTRACT: Epidemiological studies have established that sleep disorders are common and often untreated. Besides having a negative impact on overall health, these conditions can significantly disrupt normal daily functions. While a number of drugs are employed in the treatment of sleep disorders, safety, tolerability, and variable efficacy limit their utility. Clinical developments in the area have been facilitated especially by advances in neurobiology and neuropharmacology. In this regard, a wide array of neuroactive substances has been found to be responsible for regulating sleep and wakefulness. Advances in the understanding of neurotransmitter and hormone receptor mechanisms and classifications have led to new opportunities for developing novel therapeutics for treating sleep disorders. Provided in this report is an overview of some of the more prevalent sleep disorders, including narcolepsy, insomnia, obstructive sleep apnea syndrome, and restless legs syndrome, with a summary and critique of medications used to treat these conditions. For each disorder, information is provided on recent approaches taken to develop novel therapeutics based on laboratory findings relating to the underlying biological abnormalities associated with the condition, in addition to approaches that leverage existing therapeutics to develop new treatment options for patients. Significant advances in the future await a better understanding of the underlying pathophysiology of these conditions and of the neurobiological alterations associated with these disorders. It is hoped that some of the research directions described herein will stimulate additional research in this area and thereby help foster the discovery of novel agents for treating major sleep disorders.
    Advances in pharmacology (San Diego, Calif.) 01/2009; 57:187-235.
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    ABSTRACT: Divalproex sodium (DVX) is used in correctional settings to treat impulsive aggression and mood lability in patients without comorbid bipolar disorder. This review of DVX use in the Connecticut Department of Correction examined the psychiatric diagnostic impression of patients prescribed DVX, the doses used, and the symptomatic and functional change over time. Clinical charts of 168 offenders treated with DVX for one or more months were randomly selected for clinical outcome review and were divided into subgroups based on clinical impression for DVX prescription. In participants without bipolar disorder (44.6%), DVX was used to target impulsivity (14.3%) and mood lability (17.3%). Clinical improvement was noted in bipolar and nonbipolar groups (p < .001). The impulsive/aggressive subgroup was the only nonbipolar subgroup in which DVX yielded clinical benefit. This symptom-driven use of DVX is associated with clinical improvement when impulsive aggression is the target symptom.
    International Journal of Offender Therapy and Comparative Criminology 06/2008; 52(3):358-70. · 0.84 Impact Factor
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    Nicholas A DeMartinis, Paul P Yeung, Richard Entsuah, Amy L Manley
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    ABSTRACT: This study evaluated the efficacy and safety of desvenlafaxine succinate extended-release in major depressive disorder (MDD). Adult outpatients with DSM-IV-defined MDD were randomly assigned to desvenlafaxine 100 mg/day (N = 114), 200 mg/day (N = 116), or 400 mg/day (N = 113) or placebo (N = 118) for 8 weeks. Efficacy variables included change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D(17), the primary efficacy measure), Clinical Global Impressions-Improvement scale (CGI-I), Montgomery-Asberg Depression Rating Scale, Clinical Global Impressions-Severity of Illness scale (CGI-S), rates of response (> or = 50% decrease from baseline HAM-D(17) score) and remission (HAM-D(17) score < or =7), and Visual Analog Scale-Pain Intensity overall score. The study was conducted from November 2003 to November 2004. At the final on-therapy evaluation, the mean HAM-D(17) scores for desvenlafaxine 100 mg/day (12.75) and 400 mg/day (12.50) were significantly lower than for placebo (15.31; p = .0038 and p = .0023, respectively); for desvenlafaxine 200 mg/day, the mean score was 13.31 (p = .0764). CGI-I and Montgomery-Asberg Depression Rating Scale results were significant for all groups; CGI-S results were significant with 100 mg/day and 400 mg/day. Response rates were significantly greater for desven-lafaxine 100 mg/day (51%) and 400 mg/day (48%) versus placebo (35%; p = .017 and p = .046, respectively); the response rate for desvenlafaxine 200 mg/day was 45% (p = .142). Remission rates were significantly greater for desvenlafaxine 400 mg/day (32%) versus placebo (19%; p = .035); remission rates were 30% for desvenlafaxine 100 mg/day (p = .093) and 28% for desvenlafaxine 200 mg/day (p = .126). Visual Analog Scale-Pain Intensity results were significant for desvenlafaxine 100 mg/day versus placebo (p = .002), but not for the higher doses. The most commonly reported adverse events were nausea, insomnia, somnolence, dry mouth, dizziness, sweating, nervousness, anorexia, constipation, asthenia, and abnormal ejaculation/orgasm. Desvenlafaxine is effective and well tolerated in the short-term treatment of MDD.
    The Journal of Clinical Psychiatry 05/2007; 68(5):677-88. · 5.81 Impact Factor
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    Nicholas A DeMartinis, Andrew Winokur
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    ABSTRACT: Insomnia is a significant public health concern that has prompted substantial efforts to develop treatment and management strategies. A significant proportion of complaints of insomnia are related to psychiatric conditions such as anxiety disorders and depression, and treatments for these disorders are known to exert both direct and indirect benefits on sleep as well as some negative effects on sleep and sleep physiology. Insomnia is also a prominent symptom of a number of other psychiatric disorders, including schizophrenia and bipolar disorder. The observed impact of a variety of psychiatric medications on insomnia has prompted an empirically derived practice of treating non-psychiatric disorder-related insomnia with psychiatric medications by clinicians searching for alternatives to established medication treatments for primary insomnia. This article aims to review the evidence of the impact of psychiatric medications on sleep physiology, sleep disorders in psychiatric conditions, and on primary sleep disorders. The potential for exploiting the relevant pharmacological mechanisms of action in drug development for primary insomnia will be addressed as well.
    CNS & Neurological Disorders - Drug Targets (Formerly Current Drug Targets - CNS & Neurological Disorders) 03/2007; 6(1):17-29. · 3.77 Impact Factor
  • Jayesh Kamath, Nicholas DeMartinis, Venkatesh Handratta
    Future Neurology 01/2007; 2(4):361-371.
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    ABSTRACT: Sleep complaints are common in patients with major depressive disorder (MDD). Both MDD and antidepressant drugs characteristically alter objective sleep measures. This study compares the effects of mirtazapine and fluoxetine on sleep continuity measures in DSM-IV MDD patients with insomnia. Patients (N = 19) received initial baseline polysomnography evaluations over 2 consecutive nights. Subjects were randomly assigned to either fluoxetine (20-40 mg/day) or mirtazapine (15-45 mg/day) treatment for an 8-week, double-blind, double-dummy treatment trial. Single-night polysomnograms were conducted at weeks 1, 2, and 8, with depression ratings assessed at baseline and weeks 1, 2, 3, 4, 6, and 8. Statistical analysis was performed by repeated-measures analysis of variance followed by Dunnet's post hoc analyses. Patients receiving mirtazapine (N = 8) had significant improvement in objective sleep physiology measures at 8 weeks. Improvements in sleep latency, sleep efficiency, and wake after sleep onset were significant after only 2 weeks of mirtazapine treatment. No significant changes in sleep continuity measures were observed in the fluoxetine group (N = 11). Both groups improved clinically in mood and subjective sleep measures from baseline, with no differences between groups. These data demonstrate the differential effects of mirtazapine and fluoxetine, with significant improvement in favor of mirtazapine, on objective sleep parameters in MDD patients with insomnia.
    The Journal of Clinical Psychiatry 11/2003; 64(10):1224-9. · 5.81 Impact Factor
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    ABSTRACT: Generalized social anxiety disorder is an early onset, highly chronic, frequently disabling disorder with a lifetime prevalence of approximately 13%. The goal of the current study was to evaluate the efficacy and tolerability of sertraline for the treatment of severe generalized social anxiety disorder in adults. After a 1-week single-blind placebo lead-in period, patients with DSM-IV generalized social phobia were randomly assigned to 12 weeks of double-blind treatment with flexible doses of sertraline (50-200 mg/day) or placebo. Primary efficacy outcomes were the mean change in the Liebowitz Social Anxiety Scale (LSAS) total score and the responder rate for the Clinical Global Impressions-Improvement scale (CGI-I), defined as a CGI-I score </= 2. Data were collected in 2000 and 2001. 211 patients were randomly assigned to sertraline (intent-to-treat [ITT] sample, 205), and 204 patients, to placebo (ITT sample, 196). At week 12, sertraline produced a significantly greater reduction in LSAS total score compared with placebo (mean last-observation-carried-forward [LOCF] change from baseline: -31.0 vs. -21.7; p =.001) and a greater proportion of responders (CGI-I score </= 2: 55.6% vs. 29% among week 12 completers and 46.8% vs. 25.5% in the ITT-LOCF sample; p <.001 for both comparisons). Sertraline was well tolerated, with 7.6% of patients discontinuing due to adverse events versus 2.9% of placebo-treated patients. The results of the current study confirm the efficacy of sertraline in the treatment of severe social anxiety disorder.
    The Journal of Clinical Psychiatry 07/2003; 64(7):785-92. · 5.81 Impact Factor
  • European Neuropsychopharmacology - EUR NEUROPSYCHOPHARMACOL. 01/2002; 12:352-352.
  • N. Demartinis, J. Gillespie, C. Clary
    European Neuropsychopharmacology 01/2001; 11. · 4.60 Impact Factor