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 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT01764035
Eligibility Criteria:
Inclusion Criteria:
* Men and women age 18-65
* DSM-IV diagnosis of bipolar I or II disorder
* HAM-D-17 score \< 17 (i.e. low or no depressive symptoms)
* YMRS score \< 8 (i.e. no or low manic symptoms)
* Optimized, stable maintenance pharmacotherapy at maximum tolerated dosages in accordance with the revised Texas Implementation of Medication Algorithm
* DSM-IV insomnia A and B criteria are met (i.e. difficulty initiating or maintaining sleep, for at least 1 month) as operationally defined by:
1. Insomnia Severity Index score of \> 15 (moderate clinical insomnia)
2. M1 derived average actigraphic total sleep time \< 6 hours, and \< 40% average total sleep time in high frequency coupling, as measured with the M1 device over 5 days pre-randomization, corresponding to \< 1SD below the mean of the M1 normative comparison sample of healthy control participants.
Exclusion Criteria:
* 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
* Pregnancy
* Medical illness or non-psychiatric medical treatment that is the likely cause of the sleep disturbance or interferes 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; past or current substance dependence (including alcohol), schizophrenia, delusional disorder, psychotic disorders not otherwise specified
* Axis I disorder that needs to be the primary focus of treatment (e.g. current DSM-IV anxiety disorder that disrupts sleep)
* Sleep apnea, restless leg syndrome, or narcolepsy
* Concurrent psychotherapy to BS or SP.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01764035
Study Brief:
Protocol Section:
NCT01764035