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:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT01752712
Eligibility Criteria:
Inclusion Criteria:
1. DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder
2. Scale for the Assessment of Negative Symptoms asociality item score ≥ 2
3. Considered clinically stable by the treating psychiatrist
4. Stable treatment with the same antipsychotic for at least 60 days and the same dose for at least the 30 days prior to study entry.
5. Male or female of any race.
Exclusion Criteria:
1. Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, loss of consciousness (LOC) for more than 30 minutes
2. Mental retardation
3. Medical conditions, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
4. Participant is pregnant or is lactating
5. History of chronic allergic rhinitis
6. DSM-IV-TR diagnosis of alcohol or substance dependence (except nicotine) within the last 6 months, or participant has met dependence criteria for 5 years or more.
7. DSM-IV-TR diagnosis of alcohol or substance abuse (except nicotine) within the last month
8. Participant has a past history of polydypsic hyponatremia (defined by sodium levels below 130 mmol/L) or has a current sodium level below 135 mmol/L
9. Participant with EKG evidence of any of the following cardiac arrhythmias: QTc prolongation (Males: 450 msec or greater; females: 470 msec or greater); atrial fibrillation; ventricular or supraventricular tachycardia; and 2nd or 3rd degree A-V Block
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01752712
Study Brief:
Protocol Section:
NCT01752712