Antipsychotics and Neuroleptics ToxicityNCT06200584
Synergistic Effect of Vitamin E & D in Reducing Risk of Effects Associated With Atypical Anti-psychotics
A study testing Risperidone, Olanzapine and Quetiapine in people with Antipsychotics and Neuroleptics Toxicity, run by Dr Rabia Arshad at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Antipsychotics and Neuroleptics Toxicity
- What is being tested?
- Risperidone, Olanzapine and Quetiapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2021to 10 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Synergistic Effect of Vitamin E & D in Reducing the Risk of Effects Associated With Atypical Antipsychotics
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.
Read the detailed description
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
- Conditions
- Antipsychotics and Neuroleptics Toxicity
- Being tested
- Risperidone, Olanzapine, Quetiapine, Risperidone and Vitamin D and Vitamin E, Olanzapine and Vitamin D and Vitamin E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
Also called neuroleptics
Antipsychotic Agent
OlanzapineDrug
Also called neuroleptics
Antipsychotic Agent
QuetiapineDrug
Also called neuroleptics
Antipsychotic Agent
Risperidone and Vitamin D and Vitamin EDrug
Also called vitamin
vitamin
Olanzapine and Vitamin D and Vitamin EDrug
Also called vitamin
vitamin and Antipsychotic agent
Quetiapine and Vitamin D and Vitamin EDrug
Also called vitamin
Vitamin and Antipsychotic agents
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | normal healthy individuals |
| psychotic patients | Experimental | treatment given Receives: Drug: Risperidone; Drug: Olanzapine; Drug: Quetiapine; Drug: Risperidone and Vitamin D and Vitamin E; Drug: Olanzapine and Vitamin D and Vitamin E; Drug: Quetiapine and Vitamin D and Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: 6months
Lipid Profile total cholesterol
The lipid profile includes the measurement of total cholesterol level in the blood
Measured: 6months
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.
Measured: 6months
Superoxide Dismutase Activity
Superoxide Dismutase were determined in each group using a colorimetric approach and commercially available kits
Measured: 6 months
lipid profile TG
The lipid profile includes the measurement of triglycerides level in the blood
Measured: 6 months
lipid profile HDL
The lipid profile includes the measurement of high density lipoproteins in the blood
Measured: 6 months
lipid profile VLDL
The lipid profile includes the measurement of very low density lipoprotein levels level in the blood
Measured: 6 months
anti inflammatory markers TNF alpha
Tumor necrosis factor alpha expression is determined by polymerase chain reaction.
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Jan 2021
- Primary completion1 Jun 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Antipsychotics and Neuroleptics ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Rabia Arshad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Rabia Arshad, University of Karachi
- Investigators
- DR MUHAMMAD ABID, MBBS, Principal investigator, BMSI, JINNAH POST GRADUATE MEDICAL CENTRE,Karachi,Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200584
- Sponsor's protocol ID
- UKarachi2
- Status last verified
- Dec 2023
- First submitted
- 21 Nov 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22145446de 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.
PubMed 36368055Nagashima 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.
PubMed 27199286Yuan 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.
PubMed 32428979
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effect of Vitamin E & D in Reducing the Risk of Effects Associated With Atypical Antipsychotics
- ClinicalTrials.gov ID
- NCT06200584
- Acronym / sponsor ID
- UKarachi2
- Conditions
- Antipsychotics and Neuroleptics Toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Dr Rabia ArshadUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –normal healthy individuals |
| psychotic patients | Experimental | Drug: Risperidone, Drug: Olanzapine, Drug: Quetiapine, Drug: Risperidone and Vitamin D and Vitamin E, Drug: Olanzapine and Vitamin D and Vitamin E, Drug: Quetiapine and Vitamin D and Vitamin Etreatment given |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RisperidoneAlso: neurolepticsAntipsychotic Agent | Drug | psychotic patients |
| OlanzapineAlso: neurolepticsAntipsychotic Agent | Drug | psychotic patients |
| QuetiapineAlso: neurolepticsAntipsychotic Agent | Drug | psychotic patients |
| Risperidone and Vitamin D and Vitamin EAlso: vitaminvitamin | Drug | psychotic patients |
| Olanzapine and Vitamin D and Vitamin EAlso: vitaminvitamin and Antipsychotic agent | Drug | psychotic patients |
| Quetiapine and Vitamin D and Vitamin EAlso: vitaminVitamin and Antipsychotic agents | Drug | psychotic patients |
Primary outcome
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 )
Lipid Profile total cholesterol
Time frame: 6months
The lipid profile includes the measurement of total cholesterol level in the blood
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.
Superoxide Dismutase Activity
Time frame: 6 months
Superoxide Dismutase were determined in each group using a colorimetric approach and commercially available kits
lipid profile TG
Time frame: 6 months
The lipid profile includes the measurement of triglycerides level in the blood
lipid profile HDL
Time frame: 6 months
The lipid profile includes the measurement of high density lipoproteins in the blood
lipid profile VLDL
Time frame: 6 months
The lipid profile includes the measurement of very low density lipoprotein levels level in the blood
anti inflammatory markers TNF alpha
Time frame: 6 months
Tumor necrosis factor alpha expression is determined by polymerase chain reaction.
1 secondary outcome
Assessment of Psychiatric Improvement, Brief Psychiatric Rating Scale (BPRS)
Time frame: 6month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Background: PubMed 22145446Nwosu 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.
- Background: PubMed 36368055de 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.
- Background: PubMed 27199286Nagashima 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.
- Background: PubMed 32428979Yuan 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.
- Individual participant dataSharing planned: No
Related trials for Antipsychotics and Neuroleptics Toxicity
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Emergency Psychiatric, Cognition Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DR MUHAMMAD ABID, MBBS principal investigator
BMSI, JINNAH POST GRADUATE MEDICAL CENTRE,Karachi,Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risperidone, Olanzapine and Quetiapine in people with Antipsychotics and Neuroleptics Toxicity, run by Dr Rabia Arshad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glutathione Peroxidase (time frame: 6months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06200584, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.