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Randomized Double Blind Placebo Control Study in Patients with Schizophrenia

NCT01602029 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2024-12-10

No results posted yet for this study

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. 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.

Conditions

  • Schizophrenia
  • Schizoaffective Disorder
  • Psychosis Not Otherwise Specified
  • Schizophreniform Disorder

Interventions

DRUG

Ondansetron

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

DRUG

Simvastatin

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

DRUG

Placebo

Placebo added to TAU

DRUG

Odansetron plus simvastatin

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

Sponsors & Collaborators

  • Stanley Medical Research Institute

    collaborator OTHER

  • Dow University of Health Sciences

    collaborator OTHER

  • Abbasi Shaheed Hospital

    collaborator OTHER

  • Pakistan Institute of Living and Learning

    lead OTHER

Principal Investigators

  • Imran Chaudhry, MD · University of Manchester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01602029 on ClinicalTrials.gov