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 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT01892306
Eligibility Criteria:
Inclusion Criteria:
* Men and women age 18-65
* DSM-IV diagnosis of bipolar I disorder and at least one of three additional anxiety disorders:
generalized anxiety disorder, panic disorder, or social phobia.
* HAM-D-17 score \<16 (i.e. depressive symptoms)
* YMRS score \< 12 (i.e. no or very low manic symptoms)
* Current, stabilized (\> 3 months) pharmacotherapy treatment under the care of a psychiatrist consisting of optimized, stable maintenance pharmacotherapy at maximum tolerated dosages according to Texas Implementation of Medication Algorithm.
Exclusion Criteria:
* Active suicidality (HAM-D-17 suicide item #3 score \> 3) in the past 2 months. Potential participants scoring 3 or higher on the HAM-D-17 suicide item will be immediately evaluated by the PI and Sponsor and referred to a higher level of care if clinically indicated.
* DSM-IV bipolar I disorder subtype rapid cycling
* DSM-IV manic or mixed episode in the past 2 months
* DSM-IV major depressive episode in the past 2 months
* Psychotropic medication not in accordance with the revised Texas Implementation of Medication Algorithm
* Current Pregnancy
* Medical illness or non-psychiatric medical treatment that would likely interfere with study participation.
* Neurologic disorder, previous ECT, or history of head trauma (i.e. known structural brain lesion)
* Current or past history of selected DSM-IV Axis I disorders other than bipolar disorder including: organic mental disorder, substance abuse within the past 12 months and/or history of substance abuse for \> 1 year; current substance dependence (including alcohol), as assessed by the Structured Clinical Interview for DSM-IV-TR, Substance Use Disorders (Section E); schizophrenia, delusional disorder, psychotic disorders not otherwise specified, obsessive compulsive disorder and posttraumatic stress disorder (due to low prevalence of \~6.5% each).
* Concurrent psychotherapy other than cognitive-behavioral therapy as provided in this study (to rule out other uncontrolled effects of concurrent psychotherapies)
* Presence of metallic implants that would interfere with safety during fMRI scanning (i.e. cardiac pacemaker, metal plates, etc.)
* Claustrophobia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01892306
Study Brief:
Protocol Section:
NCT01892306