Bipolar Affective DisorderNCT01272531
Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder (PGBD)
An observational study of Bipolar Affective Disorder, run by University of California, San Diego at 10 sites in 3 countries.
Trial summary
This is a prospective pharmacogenomics study of mood stabilizer response. The goal of this work is to identify genes associated with good response of patients with bipolar disorder to two commonly used mood stabilizing agents, lithium and valproate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Affective Disorder
- What is being tested?
- Mood stabilizer treatment
- How many people
- 560 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Apr 2011to Apr 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatient and outpatients with bipolar affective disorder
Who may be able to join
- Any phase of bipolar I disorder including, depressive, manic, hypomanic, mixed, or baseline/euthymic/not symptomatic;
- Lithium naïve patients and inadequately past lithium treated patients will be required to have had at least one affective episode in the last 12 months meeting DSM-IV criteria. Current lithium treated patients (CLTPs) will be stable on lithium monotherapy and will be exempted from this criterion if they have had no mood episodes meeting DSM-IV criteria in the last 6 months;
- Both outpatients and inpatients will be permitted to enroll into this study;
- Able to give informed consent, in the judgment of the investigator;
- Age greater than or equal to 18 years;
- Women of child bearing potential agree to inform their doctor at the earliest possible time of their plans to conceive, and to use adequate contraception (e.g. oral contraceptives, intrauterine device, barrier methods, or total abstinence from intercourse), and to understand the risks of lithium to the fetus and infant. Depo Provera is acceptable if it is started 3 months prior to enrollment.
Who cannot join
- Unwilling or unable to comply with study requirements;
- Renal impairment (serum creatinine >1.5 mg/dL);
- Thyroid stimulating hormone (TSH) over >20% above the upper normal limit (participants maintained on thyroid medication must be euthyroid for at least 3 months before Visit 1;
- Other contraindication to lithium;
- Currently in crisis such that inpatient hospitalization or other crisis management should take priority;
- Subjects with alcohol/drug dependence who meet criteria for physical dependence requiring acute detoxification;
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- Pregnant or breastfeeding;
- Women of child-bearing potential who aren't able to agree to the requirements specified above;
- Those who have participated in a clinical trial of an investigational drug within the past 1 month;
- Inability to agree to comply with the visit schedule or study procedures;
- History of lithium toxicity, not due to mismanagement or overdose that required treatment;
- Current unstable medical condition.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States8 sites
University of Michigan
Ann Arbor, Michigan, 48109-2700
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Chicago
Chicago, Illinois, 60637
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Indiana University
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-3309
University of California San Diego
San Diego, California, 92037
About this study
This is a prospective pharmacogenomics study of mood stabilizer response. The goal of this work is to identify genes associated with good response of patients with bipolar disorder to two commonly used mood stabilizing agents, lithium and valproate.
Read the detailed description
All subjects meeting study inclusion criteria will be started on lithium. Those that fail lithium will be crossed over to valproate (VPA). Those that also fail VPA will be again crossed-over to a standardized treatment as usual (TAU) arm. Subjects who are eligible for the study must be at least 18 years of age and have been diagnosed or are thought to have bipolar I disorder with at least one episode of mood instability in the last 12 months. They must also be eligible to take lithium and, if female and of child bearing age, agree to use adequate birth control methods and to inform their doctor of their plans to become pregnant.
- Conditions
- Bipolar Affective Disorder
- Being tested
- Mood stabilizer treatment
- Keywords
- pharmacogenetics, bipolar disorders, affective disorders, mood disorders, pharmacologic actions, psychotropic drugs, antimanic agents, antidepressant agents, lithium, lithium carbonate, Lithobid, Eskalith, divalproex, divalproex sodium, Depakote, valproate
- Medical subject headings
- Bipolar Disorder, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mood stabilizer treatmentDrug
Also called lithium carbonate, Eskalith, Lithobid, divalproex sodium
lithium or valproate
| Study group | Role | What they receive |
|---|---|---|
| lithium | All study subjects will be started on lithium and taken off other medications, such as antidepressants, antipsychotic or other mood stabilizers used to control their mood. They will be stabilized over a 3 month time period, observed for one month, the followed every 2 months for 2 years. Receives: Drug: Mood stabilizer treatment | |
| valproate | Subjects that do not achieve stabilization or relapse while on lithium monotherapy will be started on valproate (VPA), in an identically designed prospective trial of VPA. Receives: Drug: Mood stabilizer treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to relapse
Relapse definition:
- meets criteria for mania and is considered "markedly ill" or worse; or
- meets criteria for major depression with 4 week duration;
- meets criteria for a mixed episode and is considered "markedly ill" or worse.
Measured: every 2 months for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar Affective DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, John Kelsoe, University of California, San Diego
- Investigators
- John R Kelsoe, M.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272531
- Sponsor's protocol ID
- NIH 1 U01 MH92758-01
- Other IDs
- U01MH092758
- Status last verified
- Jun 2020
- First submitted
- 6 Jan 2011
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Oedegaard KJ, Alda M, Anand A, Andreassen OA, Balaraman Y, Berrettini WH, Bhattacharjee A, Brennand KJ, Burdick KE, Calabrese JR, Calkin CV, Claasen A, Coryell WH, Craig D, DeModena A, Frye M, Gage FH, Gao K, Garnham J, Gershon E, Jakobsen P, Leckband SG, McCarthy MJ, McInnis MG, Maihofer AX, Mertens J, Morken G, Nievergelt CM, Nurnberger J, Pham S, Schoeyen H, Shekhtman T, Shilling PD, Szelinger S, Tarwater B, Yao J, Zandi PP, Kelsoe JR. The Pharmacogenomics of Bipolar Disorder study (PGBD): identification of genes for lithium response in a prospective sample. BMC Psychiatry. 2016 May 5;16:129. doi: 10.1186/s12888-016-0732-x.
PubMed 27150464
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder (PGBD)
- ClinicalTrials.gov ID
- NCT01272531
- Acronym / sponsor ID
- NIH 1 U01 MH92758-01
- Conditions
- Bipolar Affective Disorder
- Keywords
- pharmacogenetics, bipolar disorders, affective disorders, mood disorders, pharmacologic actions, psychotropic drugs, antimanic agents, antidepressant agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2011 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 7 Jan 2011 (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.
This is a prospective pharmacogenomics study of mood stabilizer response. The goal of this work is to identify genes associated with good response of patients with bipolar disorder to two commonly used mood stabilizing agents, lithium and valproate.
Detailed description
All subjects meeting study inclusion criteria will be started on lithium. Those that fail lithium will be crossed over to valproate (VPA). Those that also fail VPA will be again crossed-over to a standardized treatment as usual (TAU) arm. Subjects who are eligible for the study must be at least 18 years of age and have been diagnosed or are thought to have bipolar I disorder with at least one episode of mood instability in the last 12 months. They must also be eligible to take lithium and, if female and of child bearing age, agree to use adequate birth control methods and to inform their doctor of their plans to become pregnant.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lithium | – | Drug: Mood stabilizer treatmentAll study subjects will be started on lithium and taken off other medications, such as antidepressants, antipsychotic or other mood stabilizers used to control their mood. They will be stabilized over a 3 month time period, observed for one month, the followed every 2 months for 2 years. |
| valproate | – | Drug: Mood stabilizer treatmentSubjects that do not achieve stabilization or relapse while on lithium monotherapy will be started on valproate (VPA), in an identically designed prospective trial of VPA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatient and outpatients with bipolar affective disorder
Key inclusion criteria (6 listed)
- Any phase of bipolar I disorder including, depressive, manic, hypomanic, mixed, or baseline/euthymic/not symptomatic;
- Lithium naïve patients and inadequately past lithium treated patients will be required to have had at least one affective episode in the last 12 months meeting DSM-IV criteria. Current lithium treated patients (CLTPs) will be stable on lithium monotherapy and will be exempted from this criterion if they have had no mood episodes meeting DSM-IV criteria in the last 6 months;
- Both outpatients and inpatients will be permitted to enroll into this study;
- Able to give informed consent, in the judgment of the investigator;
- Age greater than or equal to 18 years;
Key exclusion criteria (12 listed)
- Unwilling or unable to comply with study requirements;
- Renal impairment (serum creatinine >1.5 mg/dL);
- Thyroid stimulating hormone (TSH) over >20% above the upper normal limit (participants maintained on thyroid medication must be euthyroid for at least 3 months before Visit 1;
- Other contraindication to lithium;
- Currently in crisis such that inpatient hospitalization or other crisis management should take priority;
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 |
|---|---|---|
| Mood stabilizer treatmentAlso: lithium carbonate, Eskalith, Lithobid, divalproex sodiumlithium or valproate | Drug | lithium, valproate |
Primary outcome
Time to relapse
Time frame: every 2 months for 2 years
Relapse definition: * meets criteria for mania and is considered "markedly ill" or worse; or * meets criteria for major depression with 4 week duration; * meets criteria for a mixed episode and is considered "markedly ill" or worse.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Derived from this study: PubMed 27150464Oedegaard KJ, Alda M, Anand A, Andreassen OA, Balaraman Y, Berrettini WH, Bhattacharjee A, Brennand KJ, Burdick KE, Calabrese JR, Calkin CV, Claasen A, Coryell WH, Craig D, DeModena A, Frye M, Gage FH, Gao K, Garnham J, Gershon E, Jakobsen P, Leckband SG, McCarthy MJ, McInnis MG, Maihofer AX, Mertens J, Morken G, Nievergelt CM, Nurnberger J, Pham S, Schoeyen H, Shekhtman T, Shilling PD, Szelinger S, Tarwater B, Yao J, Zandi PP, Kelsoe JR. The Pharmacogenomics of Bipolar Disorder study (PGBD): identification of genes for lithium response in a prospective sample. BMC Psychiatry. 2016 May 5;16:129. doi: 10.1186/s12888-016-0732-x.
- PGBD websiteLink provided by the sponsor.
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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.
John R Kelsoe, M.D. principal investigator
University of California, San Diego
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Affective Disorder, run by University of California, San Diego at 10 sites in 3 countries.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, Norway. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to relapse (time frame: every 2 months for 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01272531, which also lists 1 linked publication.
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 9 Jun 2020.