Randomized Double Blind Placebo Control Study in Patients with Schizophrenia (NCT01602029) | Clinical Trial Compass
CompletedPhase 2
Randomized Double Blind Placebo Control Study in Patients with Schizophrenia
Pakistan303 participantsStarted 2010-08
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. 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,
Exclusion criteria
✕. 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