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Randomized, Double-Blind, Parallel Group, Comparative Study of Deanxit

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Randomized, Double-Blind, Parallel Group, Comparative Study of Deanxit medicine update Randomized, double-blind, parallel group, comparative study of Deanxit (flupentixol and melitracen) versus dothiepin in the treatment of anxiety and/or depression co-morbid in general medical illness. HK Naidu ABSTRACT on the secondary efficacy parameter Consultant Psychiatrist, Lucknow. Objective: To evaluate the onset of namely the CGI-S and CGI-I, Deanxit action, efficacy and safety of Deanxit showed significantly better improvement compared to dothiepin. Jagadish A versus dothiepin in the treatment of There were more adverse effects Consultant Psychiatrist, Abhaya Hospital, anxiety and/or depression comorbid Bangalore. in general medical illness. reported on the dothiepin arm. Method: Over an 8-week period, 18- Consequently, there was significantly 65 years old Indian patients suffering more number of dropouts in the OP Singh from anxiety and/or depression dothiepin arm. The number of Associate Professor (Psychiatry), Burdwan responders was significantly more in Medical College, Burdwan. comorbid with a general medical illness participated in a randomized, the Deanxit group compared to the double blind, parallel group, dothiepin group which had significantly more number of non- Narasimha Vikram R comparative, multicenter study. responders at week-8. Clinical Pharmacologist and Assistant Patients received Deanxit as a single Professor of Pharmacology, Kempegowda fixed oral dose of 2 tablets for the first Conclusion: Deanxit is more Institute of Medical Sciences, Bangalore. week followed by a single oral tablet efficacious and better tolerated than from week 2 to week 8. Dothiepin was dothiepin (Dosulepin) in the administered as a single fixed oral treatment of anxiety and/or dose of 50 mg for the first two weeks, depression associated with co- followed by 75 mg from the third to morbid general medical disorders. eighth weeks. Patients were evaluated for anxiety, depression and rated on INTRODUCTION Hamilton rating scale for anxiety Anxiety and depressive symptoms (HAM-A), Hamilton rating scale for often occur together. Clear distinction depression (HAM-D-24 item), Clinical between anxiety and depressive Global Impressions-Severity (CGI-S) disorders cannot be made in patients and - Improvement (CGI-I). admitted to hospitals with severe Tolerability was evaluated on the systemic disorders. Both anxiety and basis of spontaneously reported depressive symptoms may be present, adverse events (AEs), severe AEs, and but are not severe enough to meet withdrawal rates. criteria for an anxiety disorder or a Corresponding author: Result: 120 patients entered the study depressive disorder. According to ICD 10, patients with this Dr. Narasimha Vikram R. and comprised the all-patients treated Assistant Professor, Department of (APTS) population. There were 9 presentation are seen frequently in Pharmacology, Kempegowda Institute of dropouts. Therefore the intent-to-treat primary care and there are many Medical Sciences (KIMS), BSK 2nd stage, population (ITT) comprised of 111 others in the general population who Bangalore - 560 070 Karnataka - INDIA subjects. Deanxit showed are not seen by doctors. Email: [email protected] significantly quicker and greater When a patient with minor Key words: Deanxit, Flupentixol, Melitracen, improvement compared to dothiepin symptoms of both anxiety and Dothiepin (dosulepin), Anxiety, Depression, on the primary efficacy parameters depression is assessed it is essential Comorbidity, General medical illness. namely HAM-D and HAM-A. Even to make sure that symptoms of more Volume 15 I Number 7 I 2007 I MEDICINE UPDATE 49 medicine update severe disorder have not been missed. Table 1. Descriptive analysis of gender (n); p>0.05 These other disorders include anxiety disorder, syndromal depressive Gender Deanxit Dothiepin Total disorder, dementia, early stages of Male 35 32 67 schizophrenia and undeclared abuse of alcohol or drugs. Physical disease Female 25 28 53 should be considered carefully as a Total 60 60 120 primary cause of the symptoms. The relative probabilities of these Table 2. Descriptive analysis of age (n=120); p>0.05 disorders vary according to the age of the patient. Deanxit Dothiepin Total The pharmacological treatment of depressive states includes at present Mean age 37.3 37.4 37.35 various classes of drugs, the most SD 12.29 11.23 11.72 important being cyclic anti- Minimum 18 18 18 depressants, monoamine oxidase inhibitors, neuroleptics in low doses, Maximum 63 60 63 5-hydroxy tryptamine and lithium. Also combination of two active Table 3. Descriptive analysis of reason for patient withdrawal (n) principles is frequently prescribed to 1 the depressive patient. Reason Deanxit Dothiepin Total Melitracen is an antidepressant that may be classified among the Patient lost for follow-up 1 8 9 thymoleptics. Its action is similar to Total 1 8 9 that of imipramine, although it enhances to a greater extent the Table 4. Descriptive analysis of primary diagnosis (n=120) adrenergic effects of adrenaline and noradrenaline. Flupentixol derived Diagnosis (%) Deanxit Dothiepin Total from thioxanthene, is a neuroleptic with a cataleptic effect and a very Depression 24 (40) 21 (35) 45 (37.5) weak sedative action. Deanxit is thus Anxiety 9 (15) 10 (16.67) 19 (15.83) the combination of a thymoleptic and Mixed anxiety and 27 (45) 29 (48.33) 56 (46.67) a neuroleptic. Consequently, it depression possesses an antidepressive action that becomes manifest through the Total 60 60 120 inhibition of impulses, the activation of vital tone, normalization of mood and side effect profiles of Deanxit general medical illness. The study and the release of the patient's (flupentixol 0.5mg and melitracen was designed to be randomized, tensions, as well as an anxiolytic 10mg) versus dothiepin to investigate double blind, parallel group and action that makes it particularly in detail its role in alleviating comparative. It was aimed to collect indicated in anxiety neuroses where symptoms associated with anxiety patient data from approximately 120 functional and organic visceral and depression in patients with patients spread across the three (somatizations) alterations are anxiety and/or depression comorbid geographically diverse locations/ common.2 in general medical illness. centers in India. The patients could Dothiepin (dosulepin) is also a enter the study (Inclusion criteria) if tricyclic antideprassant commonly METHODOLOGY they were either male or female used for low level anxiety, depression This study was for a duration of 8 outpatients or inpatients aged 18-65 and similar disorders, particularly weeks and carried out at 3 centers in years and subjects who suffer from where insomnia and/or loss of India, namely Bangalore, Lucknow anxiety and/or depression requiring appetite are present. It takes between and Burdwan. The study was pharmacological treatment which is 2-4 weeks to demonstrate clinical ethically reviewed and approved. comorbid with their general medical efficacy and is often started at low Patients gave written informed illness. The Exclusion criteria doses and the dosage is increased if consent. The objective of the study included contraindications to either required. It is very commonly was to evaluate the onset of action, of the study drugs (Deanxit/ associated with troubling side effects efficacy and safety of Deanxit Dothiepin) according to the and frequent drug interactions. (flupentixol and melitracen) versus prescribing information; current The present study is has been Dothiepin in the treatment of anxiety participation in a clinical trial; lack of conducted to compare the efficacy and/or depression comorbid in tolerability of previous treatment with 50 Volume 15 I Number 7 I 2007 I MEDICINE UPDATE medicine update Table 5. Descriptive analysis of co-morbid diagnosis (n) variables were summarized using proportions (counts and Diagnosis Deanxit Dothiepin Total percentages). Mean scores of the efficacy Hypertension 10 8 18 variables (HAM-D, HAM-A, CGI-S Acid peptic disease 9 9 18 and CGI-I) at each visit was compared with the corresponding Asthma 5 9 14 baseline values using paired-t tests to Neuropathy 7 7 14 see if there was a significant Irritable bowel syndrome 5 6 11 improvement in disease severity. All tests performed were two-sided tests Diabetes mellitus 4 4 8 and p-values < 0.05 were considered Chronic pain abdomen 4 2 6 to be significant. Chronic low back pain 3 2 5 RESULTS Migraine 2 3 5 Demographic characteristics: Osteoarthritis 3 1 4 A total of 120 subjects meeting the Ischemic heart disease 1 2 3 study criteria (both inclusion and Genito-urinary disease 1 2 3 exclusion) were enrolled; 60 each to the Deanxit and dothiepin study Psoriasis 2 1 3 arms and comprised the all-patients Post menopausal syndrome 1 2 3 treated (APTS) population and defined as those who took at least one Fibroid uterus 1 1 2 dose of study medication). This Chronic bronchitis 1 1 2 coincided with the total study Rheumatoid arthritis 1 0 1 population of all patients randomized and analyses of Total 60 60 120 demographics and other baseline characteristics as well as safety were, either Deanxit/ dothiepin; patients (HAM-D-24 item)3 and Hamilton therefore, performed for the total suffering from treatment resistant rating scale for anxiety (HAM-A)4 population of 120 study subjects. anxiety/ depression. After signing scores, where assessments to evaluate There were more males (n=67; the informed consent form, each clinical improvement were performed 55.83%) than females (n=53; 44.16%), potential study subject was screened at baseline, weeks 1, 2, 4, 6 and 8. with a mean age of 37.35 years, for eligibility based on the inclusion 2. Secondary efficacy parameter: ranging from 18 to 63 years (Tables 1- and exclusion criteria and which included Clinical Global 2). There were no statistically subsequently enrolled in the study. Impressions-Severity (CGI-S)5 where significant differences (p>0.05) in The study drugs were assessments to evaluate clinical either gender or age of patients administered as per their approved improvement were performed at between the two study arms. prescribing information.
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