Clinical trial NCT00726154: Pilot Study of the Effects of Circadian Rhythms on the Treatment of Bipolar I Depression.
Official title: Rhythmicity as a Moderator of Treatment Outcomes of Bipolar I Depression -Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder
Circadian Rhythm
Moderators
Lithium
Quetiapine
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2008-07-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of this pilot study is to test the feasibility of a larger planned trial. The objective of this larger trial will be to determine the extent to which aspects of circadian rhythmicity, including, sleep/wake rhythms, daily social routines (i.e., social rhythms), circadian type (morningness/eveningness), endogenous circadian rhythms and polymorphisms associated with altered circadian function in specific genes (namely, CLOCK, Period 2 and Period 3) moderate treatment response in bipolar disorder.

Detailed description: This study is a small scale pilot study which will be used to support a larger trial. The major aims of the larger study are to determine the extent to which aspects of circadian rhythmicity, including, sleep/wake rhythms, daily social routines (i.e., social rhythms), circadian type (morningness/eveningness), endogenous circadian rhythms and polymorphisms associated with altered circadian function in specific genes (namely, CLOCK, Period 2 and Period 3) moderate treatment response in bipolar disorder.

The overarching aim of the study is to clarify the nature of rhythm abnormalities in bipolar disorder and, especially, their relation to clinical state. We propose to do this in the context of a randomized intervention protocol in which half of the subjects will receive a treatment aimed at rhythm regularization. We expect to study individuals with a range of circadian and sleep-wake abnormalities, social rhythm disturbances, and circadian type and to examine the extent to which these parameters predict subjects' clinical outcomes. Since one half of the subjects will receive IPSRT as part of their treatment regimen (with increasing regularity of social routines as a goal of treatment), we will be able to examine the extent to which changes in social rhythm regularity and sleep quality are associated with clinical and functional improvement and whether these outcomes are mediated by changes in endogenous circadian rhythms.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 60 years
2. Able to give basic informed consent
3. Meets DSM-IV criteria for current acute episode of bipolar I depression
4. Women of childbearing potential must agree to use a doctor-approved birth control throughout participation in the study
5. Hamilton Depression Rating Scale (17-item) score \> or equal to 15
6. Hamilton Depression Rating Scale (17-item) item 1 score \> or equal to 2
7. Young Mania Rating Scale score \< or equal to 12

Exclusion Criteria:

1. Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)
2. Not competent to provide informed consent in the opinion of the investigator
3. Rapid cycling (4 or more episodes per year) bipolar I disorder
4. Present treatment for index depressive episode with lithium or quetiapine unless does or serum level are deemed inadequate
5. Lithium intolerance or a past failed adequate trial of Lithium
6. Quetiapine intolerance or a past failed adequate trial of quetiapine
7. Presence of schizophrenia, schizoaffective, antisocial or pervasive developmental disorder, psychotic disorder, current substance dependence, and organic mental disorder
8. Axis II borderline disorder
9. Mini-Mental State Examination score \<24
10. Current alcohol and illicit substance abuse
11. Women who are currently pregnant, planning to become pregnant or currently breast-feeding

Primary outcomes:
measure: This is a pilot feasibility study. The primary endpoint is depression severity at week 16, which will be measured via the Hamilton Rating Scale for Depression 25-item score (HRSD-25).
timeFrame: 2 years
Secondary outcomes:
measure: Other secondary endpoints include the social rhythm regularity, sleep/wake function, quality of life, social and occupational functioning. These will be measured by various data collection forms and questionnaires
timeFrame: 2 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Ellen Frank, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: