SchizophreniaPhase 1NCT00929955
Role of Anti-Inflammatory Agents in Patients With Schizophrenia
A Phase 1 study testing Ondansetron and Simvastatin in people with Schizophrenia and Schizoaffective Disorder, run by Pakistan Institute of Living and Learning at 2 sites in Pakistan.
Trial summary
There is some evidence that anti-inflammatory treatment may have beneficial effects in schizophrenia and major depression. Cox-2 inhibitors have been tested in preliminary clinical trials for schizophrenia and depression, showing favourable effects compared to placebo (Muller and Schwarz et al 2009). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Psychosis Not Otherwise Specified
- What is being tested?
- Ondansetron and Simvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesPakistan
- Study dates
- Jun 2009to Sep 2010
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, psychosis not otherwise specified or schizophreniform disorder
- competent and willing to give informed consent
- stable on medication 4 weeks prior to baseline
- able to take oral medication and likely to complete the required evaluations
- female participants of child bearing age must be willing to use adequate contraceptives for the duration of the study, and, willing to have a pregnancy test pre treatment and at ten weekly intervals while on study medication.
Who cannot join
- Relevant medical illness [renal and hepatic] in the opinion of the investigators
- history of high alcohol intake
- any change of psychotropic medications within the previous six weeks
- diagnosis of substance abuse (except nicotine or caffeine) or dependence within the last three months according to DSM-IV criteria
- pregnant or breast-feeding.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Dow University of Health Sciences
Karachi
Karwan e hayat
Karachi
About this study
Official title: Study of Role of Anti-Inflammatory Agents in Patients With Schizophrenia
There is some evidence that anti-inflammatory treatment may have beneficial effects in schizophrenia and major depression. Cox-2 inhibitors have been tested in preliminary clinical trials for schizophrenia and depression, showing favourable effects compared to placebo (Muller and Schwarz et al 2009).
Statins were introduced as cholesterol-lowering agents but have found much wider usage. They are anti-inflammatory agents and thus similar to the Cox-2 inhibitors, which have shown some ability as adjuncts to improve the symptoms of schizophrenia in preliminary studies. The statins are also known to decrease C-reactive protein (CRP), which has been shown in an SMRI-funded study to be elevated in a study of individuals with schizophrenia. Fan et al (2007) demonstrated in a small study in patients with schizophrenia that higher than normal levels of CRP (>0.50 mg/dl) was associated with marked negative symptoms and higher total PANSS scores.
Read more
Ondansetron is a serotonin (5-HT3) receptor antagonist that is generic and widely used to prevent nausea and vomiting in patients receiving chemotherapy for cancer. GSK did a small study on it as an antipsychotic in the 1980s. Since then, several small studies have suggested that it is effective as an adjunct drug in improving the symptoms of schizophrenia.
Statins are widely used in schizophrenia sufferers, particularly those taking second generation antipsychotics, to treat hypercholesterolemia. Both drugs are well tolerated and their side effect profiles well understood.
We propose to conduct a feasibility study in patients with chronic schizophrenia to explore the adjunct use of simvastatin and ondansetron on positive, negative and general psychopathology in comparisons to treatment as usual (TAU) over a 12 week period.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Psychosis Not Otherwise Specified, Schizophreniform Disorder
- Being tested
- Ondansetron, Simvastatin, Placebo
- Keywords
- Anti inflammatory, Schizophrenia, Simvastatin, ondansetron
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
ondansetron added to TAU Ondansetron will be administered in 8mg once daily dose
SimvastatinDrug
Simvastatin added to TAU Simvastatin 20mg taken as once daily dose
PlaceboDrug
Placebo added to TAU
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Active comparator | Not described Receives: Drug: Ondansetron |
| Simvastatin | Active comparator | Not described Receives: Drug: Simvastatin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
acceptability and tolerability of simvastatin and ondansetron added to TAU
Measured: 3 months
Secondary outcomes (3)
simvastatin and ondansetron added to TAU prevents the accumulation of negative symptoms in patients with schizophrenia
Measured: 3 months
simvastatin and ondansetron added to TAU prevents cognitive decline
Measured: 3 months
To compare the effect size
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2009
- Study completionSep 2010
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- Karwan e Hayat, Dow University of Health Sciences
- Investigators
- Imran B Chaudhry, MD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929955
- Sponsor's protocol ID
- PILL-UoM-0110
- Status last verified
- Aug 2019
- First submitted
- 28 Jun 2009
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Role of Anti-Inflammatory Agents in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00929955
- Acronym / sponsor ID
- PILL-UoM-0110
- Conditions
- Schizophrenia, Schizoaffective Disorder, Psychosis Not Otherwise Specified, Schizophreniform Disorder
- Keywords
- Anti inflammatory, Schizophrenia, Simvastatin, ondansetron
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- Karwan e Hayat, Dow University of Health Sciences
- Study start
- Jun 2009 (actual)
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 30 Jun 2009 (estimated)
- 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.
There is some evidence that anti-inflammatory treatment may have beneficial effects in schizophrenia and major depression. Cox-2 inhibitors have been tested in preliminary clinical trials for schizophrenia and depression, showing favourable effects compared to placebo (Muller and Schwarz et al 2009).
Statins were introduced as cholesterol-lowering agents but have found much wider usage. They are anti-inflammatory agents and thus similar to the Cox-2 inhibitors, which have shown some ability as adjuncts to improve the symptoms of schizophrenia in preliminary studies. The statins are also known to decrease C-reactive protein (CRP), which has been shown in an SMRI-funded study to be elevated in a study of individuals with schizophrenia. Fan et al (2007) demonstrated in a small study in patients with schizophrenia that higher than normal levels of CRP (>0.50 mg/dl) was associated with marked negative symptoms and higher total PANSS scores.
Ondansetron is a serotonin (5-HT3) receptor antagonist that is generic and widely used to prevent nausea and vomiting in patients receiving chemotherapy for cancer. GSK did a small study on it as an antipsychotic in the 1980s. Since then, several small studies have suggested that it is effective as an adjunct drug in improving the symptoms of schizophrenia.
Statins are widely used in schizophrenia sufferers, particularly those taking second generation antipsychotics, to treat hypercholesterolemia. Both drugs are well tolerated and their side effect profiles well understood.
We propose to conduct a feasibility study in patients with chronic schizophrenia to explore the adjunct use of simvastatin and ondansetron on positive, negative and general psychopathology in comparisons to treatment as usual (TAU) over a 12 week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ondansetron | Active comparator | Drug: Ondansetron |
| Simvastatin | Active comparator | Drug: Simvastatin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, psychosis not otherwise specified or schizophreniform disorder
- competent and willing to give informed consent
- stable on medication 4 weeks prior to baseline
- able to take oral medication and likely to complete the required evaluations
- female participants of child bearing age must be willing to use adequate contraceptives for the duration of the study, and, willing to have a pregnancy test pre treatment and at ten weekly intervals while on study medication.
Key exclusion criteria (5 listed)
- Relevant medical illness [renal and hepatic] in the opinion of the investigators
- history of high alcohol intake
- any change of psychotropic medications within the previous six weeks
- diagnosis of substance abuse (except nicotine or caffeine) or dependence within the last three months according to DSM-IV criteria
- pregnant or breast-feeding.
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 |
|---|---|---|
| Ondansetronondansetron added to TAU Ondansetron will be administered in 8mg once daily dose | Drug | Ondansetron |
| SimvastatinSimvastatin added to TAU Simvastatin 20mg taken as once daily dose | Drug | Simvastatin |
| PlaceboPlacebo added to TAU | Drug | Placebo |
Primary outcome
acceptability and tolerability of simvastatin and ondansetron added to TAU
Time frame: 3 months
3 secondary outcomes
simvastatin and ondansetron added to TAU prevents the accumulation of negative symptoms in patients with schizophrenia
Time frame: 3 months
simvastatin and ondansetron added to TAU prevents cognitive decline
Time frame: 3 months
To compare the effect size
Time frame: 3 months
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 5 Aug 2019.
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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.
Imran B Chaudhry, MD principal investigator
University of Manchester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ondansetron and Simvastatin in people with Schizophrenia and Schizoaffective Disorder, run by Pakistan Institute of Living and Learning at 2 sites 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 5 inclusion and 5 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 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
acceptability and tolerability of simvastatin and ondansetron added to TAU (time frame: 3 months). 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 5 Aug 2019.