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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT01012167
Eligibility Criteria:
Inclusion Criteria:
* Any race
* Subjects will meet DSM-IV criteria for schizophrenia or schizoaffective disorder
* Judged clinically stable and will not exceed threshold levels of positive, depressive, and/or extrapyramidal symptoms
* The minimum level of negative symptoms will be defined as follows:
* Scale for the Assessment of Negative Symptoms (SANS) total score (minus the global items, and inappropriate affect, poverty of content of speech and attentional items) 20 or greater; OR
* SANS alogia global item score 3 or greater
* The maximum level of psychotic, depressive, and extrapyramidal symptoms at the beginning and end of leading in:
* Brief Psychiatric Rating Scale (BPRS) psychotic factor score (4-items) less or equal to 16
* BPRS Anxiety/Depression factor score (4-items) less than or equal to 14
* Simpson-Angus-Scale (SAS) total score (13-items) less than or equal to 10
* Subjects will be required to be on the same antipsychotic(s) for two months and on the same dose for the last month
Exclusion Criteria:
* Participants with an organic brain disorder; mental retardation; or a medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
* Participants with intermittent alcohol or substance use will not be excluded unless they have met DSM-IV criteria for alcohol or substance abuse (other than nicotine) within the last month.
* Participants may be treated with one or more antipsychotics, except chlorpromazine, thioridazine, or mesoridazine. These latter antipsychotics are excluded because of the concern that their anticholinergic properties may interfere with the accurate assessment of galantamine efficacy.
* Participants may not be treated with anticholinergic medications or have clinically significant extrapyramidal symptoms. Additionally, subjects treated with glycopyrrolate will be accepted.
* Female participants may not be pregnant
* Female subjects may not be taking olanzapine at doses higher than 30 mg . Male subjects may not be taking olanzapine at doses higher than 40 mg.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01012167
Study Brief:
Protocol Section:
NCT01012167