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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT00762866
Eligibility Criteria:
Inclusion Criteria:
1. Between the ages of 16 and 65
2. Able and willing to provide informed consent
3. Able to read and speak English sufficiently to provide consent and answer questions
4. Diagnosis of one of the following:
* Unipolar Major Depressive Disorder of any subtype
* Bipolar I, Bipolar II Disorder, or Bipolar Disorder NOS
* Axis I Psychotic Disorder, which can include the diagnoses of Schizophrenia, Schizoaffective Disorder, Major Depression or Mania with Psychotic Features, Schizophreniform Disorder, Brief Psychotic Episode, or Psychotic Disorder NOS
* Normal volunteer controls, individuals with no personal history of any Axis I disorder.
Exclusion Criteria:
1. Reported pregnancy or breastfeeding
2. Dementia or delirium
3. Any medical condition that would interfere with participation in the study. This would include, but not be limited to:
* uncontrolled diabetes, hypothyroidism, Cushing's disease, or other significant endocrine condition (treated endocrine condition is allowed)
* demyelinating disease
* HIV infection
* active hepatitis
* CNS infection
* clinically significant and unstable cardiovascular disease
* any cancer involving the CNS (including metastatic disease)
4. Exclusion criteria for normal control subjects include any history of mental illness or psychotropic drug abuse.
5. Participants will be excluded from the imaging portion of the study if they have any condition deemed to interfere with PET or MRI scanning, such as but not restricted to extreme obesity, metal fragments in eyes, metal implants in the head, or cochlear implant. These participants may still take part in the portion of the study involving the clinical assessment and providing biological samples.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
65 Years
Study:
NCT00762866
Study Brief:
Protocol Section:
NCT00762866