Antipsychotics and Neuroleptics Toxicity
Conditions
Brief 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.
Detailed 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
Interventions
DRUGRisperidone
Antipsychotic Agent
DRUGOlanzapine
Antipsychotic Agent
DRUGQuetiapine
Antipsychotic Agent
DRUGRisperidone and Vitamin D and Vitamin E
vitamin
DRUGOlanzapine and Vitamin D and Vitamin E
vitamin and Antipsychotic agent
DRUGQuetiapine and Vitamin D and Vitamin E
Vitamin and Antipsychotic agents
Sponsors
Dr Rabia Arshad
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| anti inflammatory markers TNF alpha | 6 months | Tumor necrosis factor alpha expression is determined by polymerase chain reaction. |
| Glutathione Peroxidase | 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 ) |
| Lipid Profile total cholesterol | 6months | The lipid profile includes the measurement of total cholesterol level in the blood |
| anti inflammatory markers gamma interferon | 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. |
| Superoxide Dismutase Activity | 6 months | Superoxide Dismutase were determined in each group using a colorimetric approach and commercially available kits |
| lipid profile TG | 6 months | The lipid profile includes the measurement of triglycerides level in the blood |
| lipid profile HDL | 6 months | The lipid profile includes the measurement of high density lipoproteins in the blood |
| lipid profile VLDL | 6 months | The lipid profile includes the measurement of very low density lipoprotein levels level in the blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Psychiatric Improvement, Brief Psychiatric Rating Scale (BPRS) | 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 |
Countries
Pakistan
Outcome results
None listed