Pilot Study of the Effects of Circadian Rhythms on the Treatment of Bipolar I Depression.

NCT00726154 | Withdrawn

• 1 other identifier: 08020410
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Circadian Rhythm; Moderators; Lithium; Quetiapine

Outcome Measures

Primary Outcomes (1)

• 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).

  2 years

Secondary Outcomes (1)

• 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

  2 years

Study Arms (2)

IPSRT

OTHER

Interpersonal and social rhythm therapy (IPSRT) focuses specifically on rhythmicity. IPSRT is based on the social zeitgeber hypothesis (Ehlers et al., 1988; 1993) and the conviction that regularity of social routines and stability of interpersonal relationships have a protective effect in recurrent mood disorders. In IPSRT, resolution of depressive symptoms is theorized to come about through the exploration of the links among mood symptoms, stability of social rhythms and quality of social relationships and social role performance, and the identification and management of potential precipitants of rhythm disruption.

Behavioral: IPSRT

Collaborative care

OTHER

The collaborative care (CC) condition is a less intensive psychosocial intervention that was employed as the control condition in the STEP-BD study of psychosocial treatment (see Miklowitz et al., 2007). Participants assigned to this condition will receive a psychoeducational videotape and a workbook including information about: 1) the diagnosis, management, and treatment of bipolar illness; 2) the importance of medication adherence; 3) schedule management including daily mood charting; 4) typical biases in thinking relevant to mood states; 5) improving relationships through communication skills; and 6) developing a treatment contract geared toward preventing episodes.

Behavioral: Collaborative Care

Interventions

IPSRT BEHAVIORAL

Interpersonal and social rhythm therapy (IPSRT) focuses specifically on rhythmicity. IPSRT is based on the social zeitgeber hypothesis (Ehlers et al., 1988; 1993) and the conviction that regularity of social routines and stability of interpersonal relationships have a protective effect in recurrent mood disorders. In IPSRT, resolution of depressive symptoms is theorized to come about through the exploration of the links among mood symptoms, stability of social rhythms and quality of social relationships and social role performance, and the identification and management of potential precipitants of rhythm disruption.

Also known as: Psychotherapy

IPSRT

Collaborative Care BEHAVIORAL

The collaborative care (CC) condition is a less intensive psychosocial intervention that was employed as the control condition in the STEP-BD study of psychosocial treatment (see Miklowitz et al., 2007). Participants assigned to this condition will receive a psychoeducational videotape and a workbook including information about: 1) the diagnosis, management, and treatment of bipolar illness; 2) the importance of medication adherence; 3) schedule management including daily mood charting; 4) typical biases in thinking relevant to mood states; 5) improving relationships through communication skills; and 6) developing a treatment contract geared toward preventing episodes.

Also known as: psychotherapy

Collaborative care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Ellen Frank, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 31, 2008
• Study Start: June 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: January 11, 2012

Record last verified: 2012-01

Locations

US (1)