Synergistic Effect of Vitamin E & D in Reducing Risk of Effects Associated With Atypical Anti-psychotics

Antipsychotics and Neuroleptics Toxicity Clinical Trial

Official title:

Synergistic Effect of Vitamin E & D in Reducing the Risk of Effects Associated With Atypical Antipsychotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06200584
• Other study ID #: UKarachi2
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 10, 2021

Study information

• Verified date: December 2023
• Source: University of Karachi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Atypical antipsychotic drugs are commonly used to treat psychiatric illnesses but they are significantly associated with side effects including acute dystonia, akathisia, parkinsonism (rigidity and tremor), tardive dyskinesia, bradycardia, hypotension, impotence, sleepiness, seizures, severe dreams or nightmares, and hyperprolactinaemia. Vitamin D and E, have been the focus of much research in the past fifteen years, which has revealed multiple roles in the development and function of the body. According to mounting data from the domains of epidemiology and neuroscience, vitamin D and E deficiency have been related to a number of neuropsychiatric issues as well as neurodegenerative diseases. Additionally, antioxidants like vitamin E help to prevent inflammation and highly reactive oxygen molecules from damaging normal cells. The use of vitamin E and D supplements has been suggested to improve the overall outcomes of psychiatric illnesses and neurological diseases. However, the synergistic effect of vitamins E and D in reducing the risk of the adverse effects associated with atypical antipsychotics and improvement in psychiatric illness is not well understood. Therefore, this study was designed to investigate the potential synergistic effect of vitamin E and D supplements for reducing the adverse effects associated with atypical antipsychotics.

Description:

Inclusion Criteria:

1. Patients using antipsychotic medications such as quetiapine, olanzapine, or risperidone 3. Participants who are between the ages of 20 - 70 years 3. Both gender patients male and female 4. Patients with no other chronic morbidity

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 10, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Those using antipsychotic medications such as quetiapine, olanzapine, or risperidone.

2. Participants who are between the ages of 20 - 70 years are both sex male and female

3. participants who are taking a combination of one or two antipsychotics.

4. Participants who were under antipsychotic therapy and not diagnosed with type 2 diabetes mellitus.

Exclusion Criteria:

1. Patients at mental hospitals are mostly women who are either pregnant or nursing.

2. Patients who were taking anticonvulsants, ketoconazole, or corticosteroids, or who had a history of other mental or neurologic illnesses, as well as those who used phosphor, calcium, vitamin D supplements or teriparatide, were not included in the study.

3. Participants were also ruled out if they had preexisting conditions including renal or hepatic failure or a parathyroid disease

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Related Conditions & MeSH terms

• Antipsychotics and Neuroleptics Toxicity

Intervention

Drug:
• Risperidone
Antipsychotic Agent
• Olanzapine
Antipsychotic Agent
• Quetiapine
Antipsychotic Agent
• Risperidone and Vitamin D and Vitamin E
vitamin
• Olanzapine and Vitamin D and Vitamin E
vitamin and Antipsychotic agent
• Quetiapine and Vitamin D and Vitamin E
Vitamin and Antipsychotic agents

Locations

Country	Name	City	State
Pakistan	Jinnah Post Graduate Medical Centre	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dr Rabia Arshad

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

de Bartolomeis A, Ciccarelli M, Vellucci L, Fornaro M, Iasevoli F, Barone A. Update on novel antipsychotics and pharmacological strategies for treatment-resistant schizophrenia. Expert Opin Pharmacother. 2022 Dec;23(18):2035-2052. doi: 10.1080/14656566.2022.2145884. Epub 2022 Nov 17. — View Citation

Nagashima T, Shirakawa H, Nakagawa T, Kaneko S. Prevention of antipsychotic-induced hyperglycaemia by vitamin D: a data mining prediction followed by experimental exploration of the molecular mechanism. Sci Rep. 2016 May 20;6:26375. doi: 10.1038/srep26375. — View Citation

Nwosu BU, Meltzer B, Maranda L, Ciccarelli C, Reynolds D, Curtis L, King J, Frazier JA, Lee MM. A potential role for adjunctive vitamin D therapy in the management of weight gain and metabolic side effects of second-generation antipsychotics. J Pediatr Endocrinol Metab. 2011;24(9-10):619-26. doi: 10.1515/jpem.2011.300. — View Citation

Yuan T, Wang S, Le J, Li Y. Effects of Atypical Antipsychotics on Neuroactive Vitamins in Patients With Schizophrenia. J Clin Pharmacol. 2020 Oct;60(10):1355-1361. doi: 10.1002/jcph.1625. Epub 2020 May 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glutathione Peroxidase	Serum levels of Glutathione Peroxidase would be determined in each group using a colorimetric approach and commercially available kits because both enzymes are commonly involved in the response to oxidative stress in tissue.(GPX ELISA kit )	6months
Primary	Lipid Profile total cholesterol	The lipid profile includes the measurement of total cholesterol level in the blood	6months
Primary	anti inflammatory markers gamma interferon	Expression levels of interferon gamma are determined by polymerase chain reaction. Primers specific to TNF- and IFN- were designed and synthesized for use in polymerase chain reaction (PCR) copy synthesis.	6months
Primary	Superoxide Dismutase Activity	Superoxide Dismutase were determined in each group using a colorimetric approach and commercially available kits	6 months
Primary	lipid profile TG	The lipid profile includes the measurement of triglycerides level in the blood	6 months
Primary	lipid profile HDL	The lipid profile includes the measurement of high density lipoproteins in the blood	6 months
Primary	lipid profile VLDL	The lipid profile includes the measurement of very low density lipoprotein levels level in the blood	6 months
Primary	anti inflammatory markers TNF alpha	Tumor necrosis factor alpha expression is determined by polymerase chain reaction.	6 months
Secondary	Assessment of Psychiatric Improvement, Brief Psychiatric Rating Scale (BPRS)	The Brief Mental Rating Scale (BPRS) is a frequently used measure in psychiatry for assessing the severity of various mental symptoms. It is intended to assess the psychological and behavioral features of those suffering from mental health issues. The BPRS is made up of 18 components, each reflecting a different symptom domain. maximum score 168 and minimum score 24	6month