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:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT02237235
Eligibility Criteria:
Inclusion Criteria:
1. All patients must be capable of giving written informed consent.
2. Male or female subjects of any race; between 18 to 60 years of age, inclusive.
3. No hospitalization other than for evaluation in the past four months
4. Resides in a stable living situation, according to the investigator's judgment.
5. Diagnosis of schizophrenia or schizoaffective disorder of at least one-year duration, as established by the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID-I), and verified with medical records and/or confirmation of diagnosis by the treating clinician. The illness is in a nonacute phase as determined by the subject's primary treating clinician
6. Current psychotropic drug treatment consists of monotherapy with an atypical antipsychotic drug.
7. No more than a mild level of extrapyramidal symptoms (EPS) as determined by the Simpson Angus Scale (SAS) total score: ≤ 6
8. Not taking anticholinergic medication for EPS
9. No evidence of tardive dyskinesia
10. Subjects healthy enough to complete a 9-week clinical trial
11. Women of childbearing potential must have a negative pregnancy test at screening and baseline, and agree to use adequate protection (i.e. double barrier method) for birth control.
12. Able to complete cognition assessments in English
13. General intellectual abilities falling broadly within the average estimated intelligence quotient (IQ) \> 80, as measured by the Wide Range Achievement Test - 4th Edition (WRAT-IV).
Exclusion Criteria:
1. Failure to perform screening or baseline examinations
2. Hospitalization within 8 weeks before screening, or change of antipsychotic medication or dose within 2 months prior to screening
3. Subjects who have participated in another clinical trial with an experimental medication within the past 2 months.
4. Patient has had cognitive battery similar to those used in this study within the last 12 months
5. Subjects with other Diagnostic and Statistical Manual (DSM-V) Axis I or Axis II primary diagnoses
6. Diagnosis of alcohol or substance abuse or dependence within the past 3 months,
7. Significant suicide risk as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)
8. Subjects who plan to begin a new course of cognitive remediation therapy, or have been receiving cognitive remediation therapy for less than one year. .
9. History of myocardial infarction, unstable angina, uncontrolled hypotension or hypertension within 3 months before screening.
10. Clinically significant abnormality on screening ECG
11. Alanine transaminase (ALT) or aspartate transaminase (AST) \> 2.5 times the upper limit of normal (ULN)
12. History of stroke, brain tumor, head trauma with loss of consciousness, or other clinically significant neurological condition within 12 months before screening
13. Subjects with other uncontrolled medical conditions, in the opinion of the investigator
14. Polypharmacy with two or more antipsychotic drugs or mood stabilizers
15. Use of benzodiazepines
16. Individuals with kidney dysfunction will not be enrolled, as dysfunctional kidneys may have difficulty clearing the magnesium from the body
17. Individuals who are currently taking magnesium supplements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02237235
Study Brief:
Protocol Section:
NCT02237235