SchizophreniaPhase 2NCT04761861
Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia
A Phase 2 study testing Vildagliptin 50 MG in people with Schizophrenia and Dyslipidemias, run by Sadat City University at 1 site in Egypt.
Trial summary
Almost all antipsychotics can induce dyslipidemia, but no treatment has been established. Vildagliptin can improve lipid levels in obese patients. The investigators conducted a randomized, placebo-controlled study to test the efficacy of vildagliptin for antipsychotic-induced dyslipidemia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Dyslipidemias
- What is being tested?
- Vildagliptin 50 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Feb 2021to 31 Dec 2025
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-Ⅳ) criteria for schizophrenia dyslipidemia after antipsycotic treatment the duration of illness was less than 12 months taking only one antipsychotic stable outpatient the total score of Positive and Negative Syndrome Scale (PANSS)≤60.
Who cannot join
- liver or renal diseases pregnant or lactating women cardiovascular diseases hypertension or diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia: a Randomized, Double-blind, Placebo-controlled Study
Almost all antipsychotics can induce dyslipidemia, but no treatment has been established. Vildagliptin can improve lipid levels in obese patients. The investigators conducted a randomized, placebo-controlled study to test the efficacy of vildagliptin for antipsychotic-induced dyslipidemia.
- Conditions
- Schizophrenia, Dyslipidemias
- Being tested
- Vildagliptin 50 MG, Placebo
- Medical subject headings
- Schizophrenia, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vildagliptin 50 MGDrug
Vildagliptin 50 MG tablet once daily
PlaceboDrug
Placebo one tablet daily
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin | Experimental | Vildagliptin 50 mg tablet daily Receives: Drug: Vildagliptin 50 MG |
| Placebo | Placebo comparator | Placebo tablet daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
low-density lipoprotein cholesterol
low-density lipoprotein cholesterol
Measured: week 12
Secondary outcomes (5)
high-density lipoprotein cholesterol
high-density lipoprotein cholesterol
Measured: week 12
Serum stem cell growth factor beta
Serum stem cell growth factor beta
Measured: week 12
FAM19A5 serum level
FAM19A5 serum level
Measured: 12 weeks
TNF-alpha serum level
TNF-alpha serum level
Measured: 12 weeks
Adverse drug reactions
Adverse drug reactions
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start16 Feb 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Institutional and funding constrains
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sadat City University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Samy Abdallah, Sadat City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761861
- Sponsor's protocol ID
- 10/2021NEUR
- Status last verified
- Jul 2025
- First submitted
- 16 Feb 2021
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia: a Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04761861
- Acronym / sponsor ID
- 10/2021NEUR
- Conditions
- Schizophrenia, Dyslipidemias
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Institutional and funding constrains
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sadat City UniversityUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Feb 2021 (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.
Almost all antipsychotics can induce dyslipidemia, but no treatment has been established. Vildagliptin can improve lipid levels in obese patients. The investigators conducted a randomized, placebo-controlled study to test the efficacy of vildagliptin for antipsychotic-induced dyslipidemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin | Experimental | Drug: Vildagliptin 50 MGVildagliptin 50 mg tablet daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet daily |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-Ⅳ) criteria for schizophrenia dyslipidemia after antipsycotic treatment the duration of illness was less than 12 months taking only one antipsychotic stable outpatient the total score of Positive and Negative Syndrome Scale (PANSS)≤60.
Key exclusion criteria (1 listed)
- liver or renal diseases pregnant or lactating women cardiovascular diseases hypertension or diabetes mellitus
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 |
|---|---|---|
| Vildagliptin 50 MGVildagliptin 50 MG tablet once daily | Drug | Vildagliptin |
| PlaceboPlacebo one tablet daily | Drug | Placebo |
Primary outcome
low-density lipoprotein cholesterol
Time frame: week 12
low-density lipoprotein cholesterol
5 secondary outcomes
high-density lipoprotein cholesterol
Time frame: week 12
Serum stem cell growth factor beta
Time frame: week 12
FAM19A5 serum level
Time frame: 12 weeks
TNF-alpha serum level
Time frame: 12 weeks
Adverse drug reactions
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vildagliptin 50 MG in people with Schizophrenia and Dyslipidemias, run by Sadat City University at 1 site in Egypt.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 14 Jul 2025. 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
low-density lipoprotein cholesterol (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2025.