Bipolar DisorderRhythmsNCT00726154
Pilot Study of the Effects of Circadian Rhythms on the Treatment of Bipolar I Depression.
A study testing IPSRT and Collaborative Care in people with Bipolar Disorder, run by University of Pittsburgh at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- IPSRT and Collaborative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Rhythmicity as a Moderator of Treatment Outcomes of Bipolar I Depression -Pilot Study
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.
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- IPSRT, Collaborative Care
- Keywords
- Bipolar Disorder, Circadian Rhythm, Moderators, Lithium, Quetiapine
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPSRTBehavioural
Also called Psychotherapy
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.
Collaborative CareBehavioural
Also called psychotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Collaborative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startJun 2009
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: This study did not receive funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen Frank, Ph.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726154
- Sponsor's protocol ID
- 08020410
- Acronym
- Rhythms
- Status last verified
- Jan 2012
- First submitted
- 28 Jul 2008
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhythmicity as a Moderator of Treatment Outcomes of Bipolar I Depression -Pilot Study
- ClinicalTrials.gov ID
- NCT00726154
- Acronym / sponsor ID
- Rhythms / 08020410
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Circadian Rhythm, Moderators, Lithium, Quetiapine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study did not receive funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 31 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPSRT | Other | Behavioral: IPSRTInterpersonal 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. |
| Collaborative care | Other | Behavioral: Collaborative CareThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPSRTAlso: PsychotherapyInterpersonal 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. | Behavioural | IPSRT |
| Collaborative CareAlso: psychotherapyThe 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. | Behavioural | Collaborative care |
Primary outcome
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).
Time frame: 2 years
1 secondary outcome
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
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2012.
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Frank, Ph.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPSRT and Collaborative Care in people with Bipolar Disorder, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2012.