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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT02256566
Eligibility Criteria:
Inclusion Criteria:
* Primary, current Axis I diagnosis of a mood disorder (e.g., major depressive disorder (MDD); bipolar disorder, currently depressed) or anxiety disorder (PTSD; Generalized Anxiety Disorder (GAD); Social Phobia) according to DSM-IV criteria and SCID-IV diagnosis OR must be free of any psychiatric condition (for the healthy volunteer group)
* Age 18-80
* Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process
Exclusion Criteria:
* A history of drug or alcohol abuse or dependence (DSM-IV criteria) within the previous 6 months
* Visual impairment that would affect the ability to observe the computerized exercises
* Motor impairment that would affect the ability to provide a response by quickly pressing a button
* Patients with mood congruent or mood incongruent psychotic features
* Primary, current Axis I diagnosis other than MDD, Bipolar Disorder (currently depressed), PTSD, GAD or Social Phobia
* The presence of axis II personality disorder psychopathology that, in the opinion of the investigator, will interfere with study participation
* Acute suicidal or homicidal risk (evidenced by suicidal or homicidal attempt within 6 months of screening)
* Pregnancy in women. Pregnant women are excluded from the study because research has shown that hormonal changes that occur during pregnancy can mimic and/or influence symptoms of depression. Including patterns of mood and cognition. These mood and cognitive changes could mask the effect of the cognitive training in this study, so pregnant women will be excluded for that reason. A urine pregnancy test will be administered at screening
* Enrolled participants can be currently taking standard antidepressant or mood stabilizer medication regimens, or benzodiazepine treatment for sleep as needed but not exceeding 3 nights per week. Medication regimens must be stable at the time of study enrollment (i.e., no medication has been started within 8 weeks, stopped within 6 weeks or titrated up or down within 4 weeks of study entry). No medications will be started or discontinued for the purpose of enrollment into the study
* Subjects must exhibit no or only moderate alcohol use during study participation. Subjects with current excessive use of alcohol (\> 8 ounces/day) or participants abusing substances will be ineligible for participation, as such drug use could confound the results. A urine toxicology test will be administered at screening to test for drugs of abuse
* Participants exhibiting depression symptoms in the severe range (Ham-D \> 27) will be excluded from participation as an investigational study such as this may not be suitable
* Participants exhibiting chronic MDD episodes (defined as a current episode lasting 5+ years) will be excluded from participation as an investigational study such as this may not be suitable
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02256566
Study Brief:
Protocol Section:
NCT02256566