Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT01725334
Eligibility Criteria:
Inclusion Criteria:
* Male or Female patients between the age of 25-65
* DSM IV-TR diagnosis of Schizophrenia Predominant Negative Subtype, as determined by the SANS and the Schedule for the Deficit Syndrome (SDS)
* Greater negative than positive scores on the Positive and Negative Symptoms of Schizophrenia Scale (PANSS)
* Confirmation of diagnosis by independent, non-study affiliated psychiatrist
* Disease duration of \> 5 years
* Failure of medical therapy, defined as follows:
* Failure of a minimum of three anti-psychotic treatments for specifically negative symptoms of schizophrenia (including clozapine)
* No underlying neurological disease - No other active Axis I or Axis II co-morbidity that is the focus of clinical attention
* Able to give informed consent: i)Deemed competent by two independent psychiatrists (one study psychiatrist and one non-study psychiatrist); ii) Score of \> 70 on MacCat-CR
* Able to comply with all testing and follow-up visit requirements defined by the Study Protocol
* Mini mental status examination (MMSE)score \> 25
* Pre-menopausal women must agree to use acceptable methods of birth control (radiation risk of PET)
Exclusion Criteria:
* Alcohol or substance dependence or abuse within 6 months, excluding nicotine or caffeine.
* Current suicidal ideation, plan or intent for self-harm.
* A suicide attempt in the past 1 year
* Diagnosis of Major Depressive Disorder or Bipolar Depression
* Major medical illness, cardiac pacemaker/defibrillator, and other implanted stimulator
* Likely to relocate or move to a location distant from the study site within one year of enrollment
* Any contraindication to MRI or PET scanning
* Inability to provide consent, as well as an inability to appreciate the details and risk of the trial's procedures; competence will be assessed by two independent psychiatrists (one study psychiatrist, and one non-study psychiatrist)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
60 Years
Study:
NCT01725334
Study Brief:
Protocol Section:
NCT01725334