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

Dr Rabia Arshad

Status: Completed

Conditions: Antipsychotics and Neuroleptics Toxicity

Treatments: Drug: Risperidone; Drug: Olanzapine; Drug: Quetiapine; Drug: Quetiapine and Vitamin D and Vitamin E; Drug: Olanzapine and Vitamin D and Vitamin E; Drug: Risperidone and Vitamin D and Vitamin E

Study type: Interventional

Funder types: Other

Identifiers

NCT06200584

UKarachi2

Details and patient eligibility

About

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.

Full 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

Enrollment: 140 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

control

No Intervention group

Description:

normal healthy individuals

psychotic patients

Experimental group

Description:

treatment given

Treatment:

Drug: Risperidone and Vitamin D and Vitamin E

Drug: Olanzapine and Vitamin D and Vitamin E

Drug: Quetiapine and Vitamin D and Vitamin E

Drug: Quetiapine

Drug: Olanzapine

Drug: Risperidone