Randomized Double Blind Placebo Control Study in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pakistan Institute of Learning and Living; Pakistan Institute of Living and Learning
• Collaborators: Abbasi Shaheed Hospital; Dow University of Health Sciences; Karwan e Hayat; Stanley Medical Research Institute
• Treatments: Ondansetron; Simvastatin

Criteria

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