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Completed

NCT Number: NCT06200584

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

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.

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Key information

Conditions

Antipsychotics and Neuroleptics Toxicity

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinnah Post Graduate Medical Centre

Karachi, Sindh, 75510, Pakistan

About this study

Inclusion criteria

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Those using antipsychotic medications such as quetiapine, olanzapine, or risperidone.
  • Participants who are between the ages of 20 - 70 years are both sex male and female
  • participants who are taking a combination of one or two antipsychotics.
  • Participants who were under antipsychotic therapy and not diagnosed with type 2 diabetes mellitus.

Exclusion criteria

  • Patients at mental hospitals are mostly women who are either pregnant or nursing.
  • 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.
  • Participants were also ruled out if they had preexisting conditions including renal or hepatic failure or a parathyroid disease

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Treatment and study plan

Risperidone

Drug

Antipsychotic Agent

Other names: neuroleptics

Olanzapine

Drug

Antipsychotic Agent

Other names: neuroleptics

Quetiapine

Drug

Antipsychotic Agent

Other names: neuroleptics

Risperidone and Vitamin D and Vitamin E

Drug

vitamin

Other names: vitamin

Olanzapine and Vitamin D and Vitamin E

Drug

vitamin and Antipsychotic agent

Other names: vitamin

Quetiapine and Vitamin D and Vitamin E

Drug

Vitamin and Antipsychotic agents

Other names: vitamin

Primary outcomes

  1. Glutathione Peroxidase

    Time frame: 6months

    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 )

  2. Lipid Profile total cholesterol

    Time frame: 6months

    The lipid profile includes the measurement of total cholesterol level in the blood

  3. anti inflammatory markers gamma interferon

    Time frame: 6months

    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.

  4. Superoxide Dismutase Activity

    Time frame: 6 months

    Superoxide Dismutase were determined in each group using a colorimetric approach and commercially available kits

  5. lipid profile TG

    Time frame: 6 months

    The lipid profile includes the measurement of triglycerides level in the blood

  6. lipid profile HDL

    Time frame: 6 months

    The lipid profile includes the measurement of high density lipoproteins in the blood

  7. lipid profile VLDL

    Time frame: 6 months

    The lipid profile includes the measurement of very low density lipoprotein levels level in the blood

  8. anti inflammatory markers TNF alpha

    Time frame: 6 months

    Tumor necrosis factor alpha expression is determined by polymerase chain reaction.

Secondary outcomes

  1. Assessment of Psychiatric Improvement, Brief Psychiatric Rating Scale (BPRS)

    Time frame: 6month

    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

Sponsors and collaborators

Lead sponsor

Dr Rabia Arshad

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2024
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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