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Randomized Double Blind Placebo Control Study in Patients with Schizophrenia

NCT ID: NCT01602029

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-06-30

Brief Summary

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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

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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

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Schizophrenia Schizoaffective Disorder Psychosis Not Otherwise Specified Schizophreniform Disorder

Keywords

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Anti inflammatory Schizophrenia Simvastatin Ondansetron

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ondansetron

ondansetron added to TAU Ondansetron will be administered in 8mg once daily dose

Group Type ACTIVE_COMPARATOR

Ondansetron

Intervention Type DRUG

ondansetron added to TAU Ondansetron will be administered in 8mg once daily dose

Simvastatin

Simvastatin added to TAU Simvastatin 20mg taken as once daily dose

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

Simvastatin added to TAU Simvastatin 20mg taken as once daily dose

Placebo

Placebo added to TAU

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo added to TAU

Odansetron Plus Simvastatin

Ondansetron will be administered in 8mg once daily dose and Simvastatin 20mg taken as once daily dose

Group Type ACTIVE_COMPARATOR

Odansetron plus simvastatin

Intervention Type DRUG

Ondansetron will be administered in 8mg once daily dose and Simvastatin 20mg taken as once daily dose

Interventions

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Ondansetron

ondansetron added to TAU Ondansetron will be administered in 8mg once daily dose

Intervention Type DRUG

Simvastatin

Simvastatin added to TAU Simvastatin 20mg taken as once daily dose

Intervention Type DRUG

Placebo

Placebo added to TAU

Intervention Type DRUG

Odansetron plus simvastatin

Ondansetron will be administered in 8mg once daily dose and Simvastatin 20mg taken as once daily dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients aged 18 to 65 years
2. Patients will be recruited both from inpatients and outpatients.
3. Diagnostic and Statistical Manual-IV (DSM-IV TR) diagnosis of schizophrenia, schizoaffective disorder, psychosis not otherwise specified or schizophreniform disorder
4. Competent and willing to give informed consent
5. Stable on medication 4 weeks prior to baseline
6. No planned medication change
7. Able to take oral medication and likely to complete the required evaluations
8. 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,
9. Not planning to relocate in the next 12 months

Exclusion Criteria

1. Relevant ICD 10 organic brain disease or neurological diagnoses (including ECG conduction abnormalities, neurological disorder, or an active seizure)
2. 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
3. Any change of psychotropic medications within the previous 4 weeks
4. Pregnant or lactating women and those of reproductive age without adequate contraception
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanley Medical Research Institute

OTHER

Sponsor Role collaborator

Dow University of Health Sciences

OTHER

Sponsor Role collaborator

Abbasi Shaheed Hospital

OTHER

Sponsor Role collaborator

Pakistan Institute of Living and Learning

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Imran Chaudhry, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

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Abbasi Shaheed Hospital

Karachi, Sindh, Pakistan

Site Status

Dow university of Health Sciences

Karachi, Sindh, Pakistan

Site Status

Karwan e hayat

Karachi, , Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type DERIVED
PMID: 23782463 (View on PubMed)

Related Links

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http://pill.org.pk

Website of Pakistan Institute of Learning \& Living

Other Identifiers

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roses_pill

Identifier Type: -

Identifier Source: org_study_id