A review of interventional schizophrenia trials registered in clinical trials registry of India
Keywords:Second generation antipsychotics, Randomized controlled trials, Schizophrenia, Interventional trials
Background: The current therapies for schizophrenia are targeted at reducing the severity of symptoms and they do not cure the disease. The research in this field is going on for many years. The present study was designed to access the current status of interventional studies conducted in schizophrenia based on studies registered in the CTRI.
Methods: Interventional studies for schizophrenia registered on CTRI from 2007 to May 2022 were reviewed and analysed, using the keyword “schizophrenia”. Parameters such as number of studies, year wise distribution of the studies registered, status of the studies at the time of analysis, types of study designs, randomization, blinding, geographical distribution, type of intervention.
Results: Out of 42952 studies registered with CTRI from 2007 to May 2022, 323 studies exclusively involved schizophrenia which accounts for only 0.75% of the total studies. 206 were interventional studies. Among the interventional studies 188 were randomized and 87 were blinded. Of all the interventional studies 141(68.4%) involved pharmacological interventions (Allopathy), 53 (25.7%) were non drug interventions, the rest were AYUSH. Of the 141 studies involving pharmacological interventions 28 were comparative studies with active control, 23 were addon studies, 14 were single arm efficacy and safety studies and 76 were BA/BE studies.
Conclusions: The study showed a rise in schizophrenia interventional study registries in the last 5 years. However, it highlighted the need to conduct more comparative studies with active control or efficacy and safety studies rather than BA/BE studies, in order to propose better alternatives to the existing therapy.
Schizophrenia. Available at: https://www.who. int/news-room/fact-sheets/detail/schizophrenia. Accessed on 20 November 2022.
Stępnicki P, Kondej M, Kaczor AA. Current concepts and treatments of schizophrenia. Molecules. 2018; 23(8):2087.
Sagar R, Dandona R, Gururaj G, Dhaliwal RS, Singh A, Ferrari A, et al. The burden of mental disorders across the states of India. Lancet Psychiatr. 2020;7(2): 148-61.
Ahuja N. Schizophrenia. In: Ahuja S, Ahuja N, eds. A short textbook of psychiatry. 7th ed. New Delhi: Jaypee Brothers Medical Publishers (P) Ltd; 2011:54-68.
Sinclair D, Adams CE. Treatment resistant schizophrenia: a comprehensive survey of randomised controlled trials. BMC Psychiatr. 2014;14:1-8.
Ganguly P, Soliman A, Moustafa AA. Holistic management of schizophrenia symptoms using pharmacological and non-pharmacological treatment. Front Public Health. 2018;6:166.
Stroup TS, Gray N. Management of common adverse effects of antipsychotic medications. World Psychiatr. 2018;17(3):341-56.
Valiengo LD, Goerigk S, Gordon PC, Padberg F, Serpa MH, Koebe S, et al. Efficacy and safety of transcranial direct current stimulation for treating negative symptoms in schizophrenia: a randomized clinical trial. JAMA Psychiatr. 2020;77(2):121-9.
Bhatia T, Mazumdar S, Wood J, He F, Gur RE, Gur RC, et al. A randomised controlled trial of adjunctive yoga and adjunctive physical exercise training for cognitive dysfunction in schizophrenia. Acta Neuropsychiatr. 2017;29(2):102-14.
Grover S, Chakrabarti S, Kulhara P, Avasthi A. Clinical practice guidelines for management of schizophrenia. Indian J Psychiatr. 2017;59(1):S19.
Clinical trials registry India (CTRI). Available at: https://ctri.nic.in/Clinicaltrials/login.php. Accessed on 20 November 2022.
Tandon R, Gaebel W, Barch DM, Bustillo J, Gur RE, Heckers S, et al. Definition and description of schizophrenia in the DSM-5. Schizophrenia Res. 2013; 150(1):3-10.
Meyer JM. Pharmacotherapy of psychosis and Mania. In: Brunton LL, Hilal-Dandan R, Knollmann BC, eds. Goodman & Gilman’s the pharmacological basis of therapeutics. 13th ed. New York: McGraw Hill Education; 2018:279-302.
Jyothi NU, Pradeep P, Kumar MV, Sandeep K, Ramadasu P, Rao N. Schizophrenia: psycho-social demographic profile and drug utilization study of anti-psychotics at a government medical teaching. World J Pharm Pharm Sci. 2015;4(9):1036-45.
Tripathi RK, Gajbhiye S, Jalgaonkar S, Khatri N, Sayyed M, Parkar S. Antipsychotic drug utilization and adverse drug reaction profiling in patients with schizophrenia at a tertiary Care Hospital in Western India. Cureus. 2022;14(3):23-9.
Kakunje A, Prabhu A, Es SP, Karkal R, Pookoth RK, Rekha PD. Acetazolamide for antipsychotic-associated weight gain in schizophrenia. J Clinical Psychopharmacol. 2018;38(6):652.