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      Effect of Tamoxifen and Lithium on Treatment of Acute Mania Symptoms in Children and Adolescents

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          Abstract

          Objective

          Many studies have supported the role of protein kinase C (PKC) inhibitors in the physiopathology and treatment of bipolar disorder in adults. Tamoxifen is one of the drugs with the effect of PKC inhibition. This study aimed to determine the effect of tamoxifen on the rate of improvement mania symptoms in the sample of children and adolescents with acute mania.

          Materials & Methods

          In this randomized, placebo-controlled clinical trial study, registered in www.irct.ir with the code of IRCT201410126418N3, overall 44 patients with bipolar disorder with acute manic episode were randomly assigned into treatment and control groups. The serum levels of lithium and tamoxifen among the participants in the treatment groups were 0.8 -1.1 mg and 20-40 mg per day respectively. Serum level of lithium among participants in the control group was similar. The main comparisons were made based on the Young Mania Rating Scale (YMRS) and Children Depression Inventory (CDI) scores of the participants at baseline and at the end of each study week. The pharmacological side effects of serum level of lithium were examined weekly. Analysis of Covariance(ANCOVA) test was used for the statistical analysis.

          Results

          There was no difference in the baseline score of YMRS and CDI in the treatment and control groups while a statistical significant difference (P < 0.05) in these scores was found between and within the groups.

          Conclusion

          The addition of tamoxifen to lithium causes a significant difference in reducing the symptoms of mania and depression in the treatment group compared to the control group.

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          Essential role for the PKC target MARCKS in maintaining dendritic spine morphology.

          Shelley Halpain, Barbara Calabrese (2005)
          Spine morphology is regulated by intracellular signals, like PKC, that affect cytoskeletal and membrane dynamics. We investigated the role of MARCKS (myristoylated, alanine-rich C-kinase substrate) in dendrites of 3-week-old hippocampal cultures. MARCKS associates with membranes via the combined action of myristoylation and a polybasic effector domain, which binds phospholipids and/or F-actin, unless phosphorylated by PKC. Knockdown of endogenous MARCKS using RNAi reduced spine density and size. PKC activation induced similar effects, which were prevented by expression of a nonphosphorylatable mutant. Moreover, expression of pseudophosphorylated MARCKS was, by itself, sufficient to induce spine loss and shrinkage, accompanied by reduced F-actin content. Nonphosphorylatable MARCKS caused spine elongation and increased the mobility of spine actin clusters. Surprisingly, it also decreased spine density via a novel mechanism of spine fusion, an effect that required the myristoylation sequence. Thus, MARCKS is a key factor in the maintenance of dendritic spines and contributes to PKC-dependent morphological plasticity.
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            Psychometric properties of the Farsi translation of the kiddie schedule for affective disorders and schizophrenia-present and lifetime version

            Ahmad GHANIZADEH, Mohammad Reza Mohammadi, Arash Yazdanshenas (2006)
            Background Semi-structural clinical interviews are very important in the area of mental health research and services. There were no studies of the reliability and validity of the Farsi (Persian) version of Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (K-SADS-PL) in Iran. This study compares the results of face-to-face, semi-structural interview and clinical interview by a child and adolescent psychiatrist. Method Subjects were 109 children and adolescents recruited to the child and adolescent psychiatry outpatient clinic of Hafez Hospital. Order of interview (in-psychiatrist or the semi-structural interview) was determined using random assignment within a counterbalanced framework. After, translation and back translation of K-SADS-PL, the Farsi version of K-SADS-PL was provided and used in the study. The interviewer was unaware of the child and adolescent psychiatrist diagnosis at the time of making the interview. Consensual validity, test-retest and inter-rater reliability, sensitivity, specifity, positive and negative predictive validity for the disorders were studied. Results Consensual validity of all of the psychiatric disorders was good to excellent. It was highest for panic disorder, conduct disorder, and simple phobia. Consensual validity of anorexia nervosa was 0.49. There was sufficient validity and test-retest and inter-rater reliability and good to excellent sensitivity and specifity and positive and negative predictive validity for nearly all of the disorders. Test-retest reliabilities of attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), and tic disorder were 0.81, 0.67, and 0.56; respectively. Inter-rater reliabilities of ADHD, and ODD were 0.69 and 0.69. Tic disorder, post traumatic disorder, panic disorder, and ADHD had the highest positive predictive validities. Conclusion The Farsi version of K-SADS-PL is a valid and reliable interview instrument for use in assessing and diagnosising child and adolescent psychiatric disorders.
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              Protein kinase C inhibition in the treatment of mania: a double-blind, placebo-controlled trial of tamoxifen.

              Sebnem Guleryuz, Perry Renshaw, Dost Ongur … (2008)
              Findings that protein kinase C (PKC) activity may be altered in mania, and that both lithium carbonate and valproate sodium inhibit PKC-associated signaling in brain tissue, encourage development of PKC inhibitors as candidate antimanic agents. To perform a controlled test of antimanic efficacy of the centrally active PKC inhibitor tamoxifen citrate. Three-week, randomized, double-blind, placebo-controlled, parallel-arms trial. A university medical center inpatient psychiatric unit in Izmir, Turkey. Sixty-six patients aged 18 to 60 years, diagnosed as having DSM-IV bipolar I disorder on the basis of the Structured Clinical Interview for DSM-IV, currently in a manic or mixed state, with or without psychotic features, with initial scores on the Young Mania Rating Scale (YMRS) greater than 20. Treatment with tamoxifen or identical placebo tablets for up to 3 weeks. Adjunctive lorazepam was allowed up to 5 mg/d. Primary: change in YMRS scores; secondary: change in Clinical Global Impressions-Mania scores, weekly ratings of depression and psychosis, and adjunctive use of lorazepam. The 21-day trial was completed by 29 of 35 subjects randomized to receive tamoxifen (83%) and 21 of 31 given placebo (68%) (P = .25). Intent-to-treat analysis of available measures on all 66 subjects indicated that tamoxifen treatment yielded mean decreases in scores on the YMRS and Clinical Global Impressions-Mania of 5.84 and 0.73 point per week, respectively, compared with mean increases of 1.50 and 0.10 point per week, respectively, with placebo; both drug-placebo contrasts differed significantly (P < .001). Tamoxifen demonstrated antimanic properties and was remarkably well tolerated. The findings encourage further clarification of the role of PKC in the pathophysiologic mechanism of bipolar I disorder and development of novel anti-PKC agents as potential antimanic or mood-stabilizing agents. clinicaltrials.gov Identifier: NCT00411203 and isrctn.org Identifier: ISRCTN97160532.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Iran J Child Neurol
                Journal ID (iso-abbrev): Iran J Child Neurol
                Journal ID (publisher-id): IJCN
                Title: Iranian Journal of Child Neurology
                Publisher: Shahid Beheshti University of Medical Sciences (Tehran, Iran )
                ISSN (Print): 1735-4668
                ISSN (Electronic): 2008-0700
                Publication date (Print): Spring 2016
                Volume: 10
                Issue: 2
                Pages: 16-25
                Affiliations
                [1 ]Child Psychiatry Department, Behavioral Sciences Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
                [2 ]Child Psychiatrist, Isfahan university of medical sciences, Isfahan, Iran
                [3 ]Department of Psychology, Islamic Azad University, Sharekord Branch, Sharekord, Iran
                Author notes
                Corresponding Author: Fallah E. MD, Child Psychiatry Department, Behavioral Sciences Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Tel: +989133831040, Email: elhamfallah51@yahoo.com
                Article
                Publisher ID: ijcn-10-016
                PMC ID: 4885151
                PubMed ID: 27247580
                SO-VID: f10382ce-6ef0-403a-b99e-17ac25645c05
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License, ( http://creativecommons.org/licenses/by/3.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 23 February 2015
                Date revision received : 30 May 2015
                Date accepted : 30 May 2015
                Categories
                Subject: Original Article

                Keywords: lithium,mania,protein kinase c,tamoxifen,children
                Data availability:
                Keywords: lithium, mania, protein kinase c, tamoxifen, children

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