SchizophreniaPhase 2ROSESNCT01602029
Randomized Double Blind Placebo Control Study in Patients with Schizophrenia
A Phase 2 study testing Ondansetron, Simvastatin and Odansetron plus simvastatin in people with Schizophrenia and Schizoaffective Disorder, run by Pakistan Institute of Living and Learning at 3 sites in Pakistan.
Trial summary
Negative symptoms and cognitive deficits are two partially-related features of schizophrenia which have a major negative impact on social function and objective quality of life. Standard drug treatments have little impact on either and arguably no effect on primary negative symptoms. 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, Simvastatin and Odansetron plus simvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 303 participants
- Where
- 3 sitesPakistan
- Study dates
- Aug 2010to Jun 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 65 years
- Patients will be recruited both from inpatients and outpatients.
- Diagnostic and Statistical Manual-IV (DSM-IV TR) 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
- No planned medication change
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- 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,
- Not planning to relocate in the next 12 months
Who cannot join
- Relevant ICD 10 organic brain disease or neurological diagnoses (including ECG conduction abnormalities, neurological disorder, or an active seizure)
- Subjects who will meet the criteria for a DSM-IV TR diagnosis of alcohol or substance abuse (other than for nicotine) within the last month or the criteria for DSM-IV TR alcohol or substance dependence (other than for nicotine) within the last 6 months
- Any change of psychotropic medications within the previous 4 weeks
- Pregnant or lactating women and those of reproductive age without adequate contraception
Trial locations and contacts
3 sites in 1 country.
Pakistan3 sites
Abbasi Shaheed Hospital
Karachi, Sindh
Dow university of Health Sciences
Karachi, Sindh
Karwan e hayat
Karachi
About this study
Official title: Randomized Double Blind Placebo Controlled Study of Ondansetron and Simvastatis Added to Treatment As Usual in Patients with Schizophrenia
Negative symptoms and cognitive deficits are two partially-related features of schizophrenia which have a major negative impact on social function and objective quality of life. Standard drug treatments have little impact on either and arguably no effect on primary negative symptoms. Social dysfunction has major economic consequences in both the developed and developing world. There is evidence that anti-inflammatory treatment may have beneficial effects in patients with schizophrenia.
Read the detailed description
Negative symptoms and cognitive deficits are two partially-related features of schizophrenia which have a major negative impact on social function and objective quality of life. Evidence indicates that anti-inflammatory treatment may have beneficial effects in schizophrenia. From our preliminary randomised double-blind placebo-controlled clinical trial in Pakistan and Brazil, it is indicated that addition of minocycline (an antibiotic and anti-inflammatory drug) for one year to treatment as usual (TAU) reduced negative symptoms and improved some cognitive measures (Chaudhry et al 2009).
Statins are primarily HMG-CoA reductase inhibitors also anti-inflammatory agents and known to decrease C-reactive protein (CRP). Higher levels of CRP (>0.50 mg/dl) are associated with marked negative symptoms and higher total PANSS scores in patients with schizophrenia. (Fan et al 2007)
Ondansetron, a selective 5-hydroxytryptamine-3 antagonist, is quite commonly used as an antiemetic in cancer patients (Marty et al 1990). There are several small trials suggesting that ondansetron as an adjunct to antipsychotics is effective in improving negative symptoms and memory in patients suffering from schizophrenia (Ahkonzadeh et al 2009, Levkovitz et al 2005 and Zhang et al 2006).
The Primary objective of this study is addition of ondansetron and /or simvastatin to TAU for patients with schizophrenia will result in improvement in negative symptoms
The Secondary objectives include:
- improvement in positive or other symptoms
- social functioning
- cognitive functions
- additive effects of ondansetron and simvastatin
- Conditions
- Schizophrenia, Schizoaffective Disorder, Psychosis Not Otherwise Specified, Schizophreniform Disorder
- Being tested
- Ondansetron, Simvastatin, Placebo, Odansetron plus simvastatin
- 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
Odansetron plus simvastatinDrug
Ondansetron will be administered in 8mg once daily dose and Simvastatin 20mg taken as once daily dose
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Active comparator | ondansetron added to TAU Ondansetron will be administered in 8mg once daily dose Receives: Drug: Ondansetron |
| Simvastatin | Active comparator | Simvastatin added to TAU Simvastatin 20mg taken as once daily dose Receives: Drug: Simvastatin |
| Placebo | Placebo comparator | Placebo added to TAU Receives: Drug: Placebo |
| Odansetron Plus Simvastatin | Active comparator | Ondansetron will be administered in 8mg once daily dose and Simvastatin 20mg taken as once daily dose Receives: Drug: Odansetron plus simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative symptom severity
Negative symptom severity as defined by negative syndrome subscale score on the Positive and Negative Syndrome Scale
Measured: 6 months
Secondary outcomes (1)
cognitive functioning
- Full PANSS and positive syndrome subscale score
- Clinical Global Impression
- Functional outcome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startAug 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute, Dow University of Health Sciences, Abbasi Shaheed Hospital
- Responsible party
- Sponsor
- Investigators
- Imran Chaudhry, MD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602029
- Sponsor's protocol ID
- roses_pill
- Acronym
- ROSES
- Status last verified
- May 2012
- First submitted
- 17 May 2012
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chaudhry IB, Husain N, Husain MO, Hallak J, Drake R, Kazmi A, Rahman Ru, Hamirani MM, Kiran T, Mehmood N, Stirling J, Dunn G, Deakin B. Ondansetron and simvastatin added to treatment as usual in patients with schizophrenia: study protocol for a randomized controlled trial. Trials. 2013 Apr 17;14:101. doi: 10.1186/1745-6215-14-101.
PubMed 23782463
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Placebo Controlled Study of Ondansetron and Simvastatis Added to Treatment As Usual in Patients with Schizophrenia
- ClinicalTrials.gov ID
- NCT01602029
- Acronym / sponsor ID
- ROSES / roses_pill
- Conditions
- Schizophrenia, Schizoaffective Disorder, Psychosis Not Otherwise Specified, Schizophreniform Disorder
- Keywords
- Anti inflammatory, Schizophrenia, Simvastatin, Ondansetron
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute, Dow University of Health Sciences, Abbasi Shaheed Hospital
- Study start
- Aug 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 May 2012 (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.
Negative symptoms and cognitive deficits are two partially-related features of schizophrenia which have a major negative impact on social function and objective quality of life. Standard drug treatments have little impact on either and arguably no effect on primary negative symptoms. Social dysfunction has major economic consequences in both the developed and developing world. There is evidence that anti-inflammatory treatment may have beneficial effects in patients with schizophrenia.
Detailed description
Negative symptoms and cognitive deficits are two partially-related features of schizophrenia which have a major negative impact on social function and objective quality of life. Evidence indicates that anti-inflammatory treatment may have beneficial effects in schizophrenia. From our preliminary randomised double-blind placebo-controlled clinical trial in Pakistan and Brazil, it is indicated that addition of minocycline (an antibiotic and anti-inflammatory drug) for one year to treatment as usual (TAU) reduced negative symptoms and improved some cognitive measures (Chaudhry et al 2009).
Statins are primarily HMG-CoA reductase inhibitors also anti-inflammatory agents and known to decrease C-reactive protein (CRP). Higher levels of CRP (>0.50 mg/dl) are associated with marked negative symptoms and higher total PANSS scores in patients with schizophrenia. (Fan et al 2007)
Ondansetron, a selective 5-hydroxytryptamine-3 antagonist, is quite commonly used as an antiemetic in cancer patients (Marty et al 1990). There are several small trials suggesting that ondansetron as an adjunct to antipsychotics is effective in improving negative symptoms and memory in patients suffering from schizophrenia (Ahkonzadeh et al 2009, Levkovitz et al 2005 and Zhang et al 2006).
The Primary objective of this study is addition of ondansetron and /or simvastatin to TAU for patients with schizophrenia will result in improvement in negative symptoms
The Secondary objectives include:
- improvement in positive or other symptoms
- social functioning
- cognitive functions
- additive effects of ondansetron and simvastatin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ondansetron | Active comparator | Drug: Ondansetronondansetron added to TAU Ondansetron will be administered in 8mg once daily dose |
| Simvastatin | Active comparator | Drug: SimvastatinSimvastatin added to TAU Simvastatin 20mg taken as once daily dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo added to TAU |
| Odansetron Plus Simvastatin | Active comparator | Drug: Odansetron plus simvastatinOndansetron will be administered in 8mg once daily dose and Simvastatin 20mg taken as once daily dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged 18 to 65 years
- Patients will be recruited both from inpatients and outpatients.
- Diagnostic and Statistical Manual-IV (DSM-IV TR) 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
Key exclusion criteria (4 listed)
- Relevant ICD 10 organic brain disease or neurological diagnoses (including ECG conduction abnormalities, neurological disorder, or an active seizure)
- Subjects who will meet the criteria for a DSM-IV TR diagnosis of alcohol or substance abuse (other than for nicotine) within the last month or the criteria for DSM-IV TR alcohol or substance dependence (other than for nicotine) within the last 6 months
- Any change of psychotropic medications within the previous 4 weeks
- Pregnant or lactating women and those of reproductive age without adequate contraception
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 |
| Odansetron plus simvastatinOndansetron will be administered in 8mg once daily dose and Simvastatin 20mg taken as once daily dose | Drug | Odansetron Plus Simvastatin |
Primary outcome
Negative symptom severity
Time frame: 6 months
Negative symptom severity as defined by negative syndrome subscale score on the Positive and Negative Syndrome Scale
1 secondary outcome
cognitive functioning
Time frame: 6 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 10 Dec 2024.
- Derived from this study: PubMed 23782463Chaudhry IB, Husain N, Husain MO, Hallak J, Drake R, Kazmi A, Rahman Ru, Hamirani MM, Kiran T, Mehmood N, Stirling J, Dunn G, Deakin B. Ondansetron and simvastatin added to treatment as usual in patients with schizophrenia: study protocol for a randomized controlled trial. Trials. 2013 Apr 17;14:101. doi: 10.1186/1745-6215-14-101.
- Website of Pakistan Institute of Learning \& LivingLink provided by the sponsor.
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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 Chaudhry, MD principal investigator
University of Manchester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ondansetron, Simvastatin and Odansetron plus simvastatin in people with Schizophrenia and Schizoaffective Disorder, run by Pakistan Institute of Living and Learning at 3 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 9 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 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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 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?
Negative symptom severity (time frame: 6 months). 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 NCT01602029, which also lists 1 linked publication.
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 10 Dec 2024.