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Print This Article International Journal of Advances in Medicine Kumar MS et al. Int J Adv Med. 2021 Oct;8(10):1551-1559 http://www.ijmedicine.com pISSN 2349-3925 | eISSN 2349-3933 DOI: https://dx.doi.org/10.18203/2349-3933.ijam20213642 Original Research Article Effectiveness and tolerability of eight-week treatment with dosulepin hydrochloride in patients with major depressive disorder not responding to four consecutive weeks of treatment with single selective serotonin reuptake inhibitor M. Suresh Kumar1*, Amrit Pattojoshi2 1PSYMED Hospital, Harrington Road, Shenoy Nagar, Chennai, Tamil Nadu, India 2Dr. Amrit Pattojoshi's Clinic, Bhouma Nagar, Bhubaneswar, Odisha, India Received: 12 August 2021 Accepted: 23 August 2021 *Correspondence: Dr. M. Suresh Kumar, E-mail: [email protected] Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. ABSTRACT Background: Though manageable, major depressive disorder remains an underdiagnosed and undertreated condition. The objective of this study was to assess the effectiveness and safety of 8 weeks of treatment with the tricyclic antidepressant dosulepin hydrochloride in patients with depressive episodes not responsive to 4 consecutive weeks of treatment with a single selective serotonin reuptake inhibitor (SSRI). Methods: Patients diagnosed with depressive episode without psychotic symptoms (by ICD-10 diagnostic criteria for research), mini-mental state examination score of ≥24, and not responsive to four weeks of treatment with SSRIs (<50% reduction in depressive symptoms) were enrolled. The main outcome measures were mean change in the Hamilton depression, Hamilton anxiety, and insomnia severity index scores at Week 8 compared to baseline. Adverse events were recorded for safety assessment. Results: A total of 94 patients were enrolled, of which, 90 (95.7%) patients completed the study. Compared to baseline, 8 weeks of treatment significantly changed the HAM-D score by -12.7 (p<0.0001), HAM-A score by -8.3 (p<0.0001), and ISI score by -10.5 (p<0.0001). One patient reported anemia and was withdrawn from the study. Dry mouth and insomnia followed by headache, blurred vision, and drowsiness were the most commonly reported side effects as measured with the antidepressant side-effects checklist. Most side effects were of mild intensity and were related to study medication. Conclusions: Eight weeks of treatment with dosulepin hydrochloride resulted in significant and clinically relevant improvements in depression, anxiety, and insomnia symptoms in Indian patients with MDD. Keywords: Dosulepin, Tricyclic antidepressants, Major depressive disorder, Hamilton depression score, Hamilton anxiety score, Insomnia severity index INTRODUCTION role, and in its severe form can lead to suicide3,4 and increased risk of mortality.5 MDD affects people of all Globally, major depressive disorder (MDD) is the most ages, genders, and socioeconomic groups. A meta- common psychiatric disease and a leading cause of years analysis of 91 studies published between 1994 and 2014 lived with debility.1 An incapacitating disease, MDD is by Lim et al. showed that point prevalence of depression characterized by depressed mood, diminished interests, was 12.9%; 1 year prevalence, 7.2%; and lifetime impaired cognitive function, and vegetative symptoms, prevalence, 10.8%.6 The point prevalence of depression such as disturbed sleep or appetite,2 or impaired social was found to be significantly higher in women (14.4%), International Journal of Advances in Medicine | October 2021 | Vol 8 | Issue 10 Page 1551 Kumar MS et al. Int J Adv Med. 2021 Oct;8(10):1551-1559 and in countries with a medium human development experts, requiring trial of a variety of therapeutic index (29.2%), including many Asian countries.6 interventions.19 Amid concerns about the tolerability and safety of TCAs, there is dearth of data on the effects of As per World Health Organization’s report “depression the TCA dosulepin hydrochloride in Indian patients with and other common mental disorders global health MDD in addition to a constant need to review available estimates” released in 2017, approximately 322 million evidence. Herein, we present results from a study people were affected by depression in 2015 worldwide.7 designed to evaluate the effectiveness and safety of Depression is a major public health problem in India. It is dosulepin hydrochloride in Indian patients with estimated that 57 million people (18% of the global depressive episodes not responsive to 4 consecutive estimate) are affected by depression in India,7 weeks of treatment (<50% reduction in HAM-D score) contributing significantly to disability, morbidity and with a single SSRI, of which patients had adequate doses mortality, along with significant socioeconomic losses. for at least 3 weeks. Despite the high prevalence rate, MDD remains both METHODS underdiagnosed and undertreated.8 The suggested first- line treatment for MDD includes antidepressant Study design and population medications and/or psychological-behavioral therapies.9 However, 66% of patients do not respond to initial This was a prospective, multicenter, open-label, non- antidepressant treatment.10,11 Additionally, it is estimated comparative study conducted between January 2019 and that only about 30%–35% of adults achieve remission September 2020 at 2 centers in India. Outpatients with using current therapeutic approaches, leaving over two- MDD aged 18-65 years in otherwise good physical health thirds of the disease burden intact.12 Multiple therapeutic who had been diagnosed with depressive episodes (single drug classes exist for management of MDD treatment, episode or recurrent) by the diagnostic criteria for with selective serotonin reuptake inhibitors (SSRIs) and Research (DCR) accompanying the International tricyclic antidepressants (TCAs), being the two most Classification of Diseases and Related Health Problems important.13 Though both classes of drugs are effective, (ICD-10 DCR) without psychotic symptoms, exhibiting the choice of therapy is primarily driven by patients’ treatment non-response (<50% reduction in depressive preference, with informed consent obtained for the risks symptoms) after 4 weeks of treatment with SSRIs, with of adverse effects.14,15 no cognitive impairments and a mini-mental state examination (MMSE) scale score of ≥24, and who TCAs block the reuptake of two neurotransmitters, provided signed informed consent were enrolled in this serotonin and norepinephrine. Both these chemical study. messengers are involved in regulating mood in the brain. Effective reuptake blockade increases the concentration Patients diagnosed with depressive episode (by ICD-10 of neurotransmitters in the synapse and relieves DCR) with psychotic symptoms; patients who underwent depression by hitherto not fully understood electroconvulsive therapy within 2 months; patients with mechanisms.16 However, concerns have been raised about comorbid substance abuse or history of organicity, the tolerability and safety of TCAs.16,17 SSRIs, with their patients with a history of obsessive-compulsive disorder, selective mode of action, have an improved side-effect major medical or neurological illness, glaucoma, urinary profile with good clinical efficacy.16,17 Though overall tract obstruction, recent myocardial infarction, or any efficacy of both drug classes is comparable, with an degree of heart block or other cardiac arrhythmias; overall response rate of ~60%, studies indicate that 50%- patients with severe liver disease; patients with known 75% of patients treated with TCAs respond favorably.15-17 intolerance to any of the ingredients of dosulepin; Moreover, this response rate has not been surpassed by pregnant and nursing women; women with childbearing the newer antidepressants.13,15,16,18 Additionally, evidence potential who were not practicing a reliable method of suggests that TCAs might be the preferred choice for birth control; and/or patients with a suspected inability or patients with severe MDD and MDD with melancholic unwillingness to comply with study procedures were features.13 excluded from the study. Despite advances in the treatment of MDD, 10%-30% of The total duration of the study was 8 weeks. Patients patients exhibit treatment-resistant symptoms, defined as were prescribed with dosulepin hydrochloride “<50% reduction in depressive symptoms (as assessed by (Prothiaden®, Abbott India Limited) 25 mg thrice daily the Hamilton depression [HAM-D] scale), that a change (TID) or 75 mg once daily (QD) at baseline. Patient in treatment plan is called for following 4 consecutive progress was reviewed at Weeks 2, 4, 6, and 8. If the weeks of treatment during which the patient has had an response was found inadequate, dose escalation was done adequate dose for at least 3 weeks.”19 Non-responders to as per clinical judgment of the investigators. initial treatment with antidepressants require subsequent treatment strategies such as augmentation or change of The study was conducted as per the principles of the antidepressants. This group of patients poses several Declaration of Helsinki and in compliance with Good diagnostic and therapeutic challenges to mental health Clinical Practice guidelines. Written informed consent International Journal of Advances in Medicine
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