Bipolar DisorderPhase 4NCT00732251
Allopurinol Maintenance Study for Bipolar Disorder
A Phase 4 study testing Allopurinol in people with Bipolar Disorder and Mania, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate the efficacy of allopurinol as an augmentation agent for the prevention of mania in bipolar disorder patients with currently stable mood. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bipolar Disorder, Mania, Mixed Mania
- What is being tested?
- Allopurinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jan 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be between ages 18 and 70.
- Subjects must meet diagnostic and statistical manual of mental disorders 4th edition criteria for bipolar disorder confirmed by the Mini International Neuropsychiatric Interview.
- Subjects must be taking at least one medication for mania at a therapeutic dose for at least 2 weeks.
- Subjects must have been diagnosed with bipolar disorder, type 1, for at least 2 years prior to baseline.
- Subjects must have adequate response to medications as evidenced by Young Mania Rating Scale score less than or equal to 10 at screening and at baseline.
- Subjects must have adequate response to medications as evidenced by Hamilton Depression Rating Scale score less than or equal to 10 at screening and at baseline.
Show all 12Show fewer
- Subjects must have had at least 1 manic episode in the 2 year period prior to entering the study.
- Female subjects must be either postmenopausal for at least 1 year, surgically sterile, abstinent or practicing an effective method of birth control if sexually active. Acceptable methods of birth control during this study are regular use of contraceptive pills, intra-uterine devices, barrier methods or abstinence. Female subjects must also have a negative urine pregnancy test at screening, baseline and other time points throughout the study.
- Subjects must be able and willing to comply with self-administration of medication or have consistent help/support available.
- Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Subjects must be able and willing to meet or perform study requirements (e.g. answer self-administered questionnaires).
- Subjects must be willing to allow study staff to contact subject's regular psychiatrist while the subject is in the study.
Who cannot join
- Subjects who are unable to provide informed consent.
- Subjects with a serious, unstable medical illness (such as cardiovascular, respiratory, neurologic, hematologic, renal, hepatic, endocrine, immunologic, or other systemic illness), a history of cerebrovascular disease, uncontrolled diabetes mellitus or acquired immunodeficiency syndrome (AIDS). Subjects with chronic illness must be stable and otherwise physically healthy on the basis of a physical examination, medical history, electrocardiogram and the results of blood biochemistry, hematology tests and a urinalysis.
- Subjects who develop a medical condition during participation which can affect mood stability (i.e. seizure disorder, brain tumors, brain trauma, stroke, multiple sclerosis, etc.)
- Subjects who develop substance abuse or dependence during participation in the study.
- Subjects taking azathioprine, mercaptopurine, apalcillin, and/or amoxicillin.
- Subjects who have been intoxicated with alcohol or drugs within the last 72hrs.
Show all 11Show fewer
- Subjects with a history of severe pre-existing gastrointestinal narrowing or inability to swallow oral study medication whole with the aid of water.
- Female subjects who are pregnant or nursing.
- Subjects who have previously participated in this study.
- Subjects with an anticipated life expectancy of 6 months or less.
- Subjects who have received an experimental drug or used an experimental medical device within 1 month of screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: An Open Label, Naturalistic Study With Allopurinol Augmentation for Prevention of Mania in Bipolar Disorder
The purpose of this study is to investigate the efficacy of allopurinol as an augmentation agent for the prevention of mania in bipolar disorder patients with currently stable mood.
Read the detailed description
The purpose of this study is to investigate the efficacy of allopurinol as an augmentation agent for the prevention of mania in bipolar disorder patients with currently stable mood. Bipolar disorder is a mental disorder with severe mood swings (mania and depression). Despite the development of medications for mania, they may have significant side effects, high costs and the need for serum level monitoring. These factors adversely affect medication compliance in bipolar patients. One recent study indicated the efficacy of allopurinol in the treatment of bipolar mania. Our hypothesis is that the addition of allopurinol to standard medications for bipolar disorder will decrease the recurrences of manic episodes compared to standard medications.
This study will recruit bipolar disorder patients currently mood stable on a therapeutic dose of an anti-manic medication. Stable mood will be defined as a Young Mania Rating Scale score ≤10 and Hamilton Depression Rating Scale ≤10. Subjects must have a diagnosis of bipolar disorder confirmed by the Mini International Neuropsychiatric Interview. Young Mania Rating Scale and Mini International Neuropsychiatric Interview are common research questionnaires used in bipolar disorder studies. Potential subjects will be identified and approached during an outpatient clinical visit by a member of the research team and identified by their treating physicians and referred to the researchers.
This study involves adding allopurinol to subjects' current bipolar medications. This study will be a open label, naturalistic study. The subject will be examined monthly for manic symptoms for 2 years. Semi-structured interviews and study questionnaires will be administered to subjects at each visit. Monthly Follow-up Study Visits (once per month for 2 years - Months 1-5, 7-11, 13-17, 19-23) may be conducted either in-person or over the phone. All of the questionnaires will be administered by a clinician if the visit is completed over the phone. However, the 6-month interval visits (Months 6, 12, 18, and 24) must be done at the research center.
The primary outcome measure will be the number of manic episodes in the 2 year study period. A manic episode will be defined by a Young Mania Rating Scale score ≥20.
- Conditions
- Bipolar Disorder, Mania, Mixed Mania
- Being tested
- Allopurinol
- Keywords
- Bipolar Disorder, Stable Bipolar Disorder, Mania, Mixed mania, Allopurinol
- Medical subject headings
- Bipolar Disorder, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
Also called Zyloprim, Aloprim
Allopurinol: 300-600 mg/day over a 24 month period
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol | Experimental | Using an open label, naturalistic design, subjects will continue with their current psychiatric medications during the study. Allopurinol will be given at a fixed dose of 300 mg/day for the first week and then 600mg/d for the remainder of the study. Subjects who cannot tolerate the 600mg dose will be given a dose of 300mg/d. Subjects will participate in monthly follow up visits for 24 months. Subjects who develop a substance abuse or substance dependence disorder during the study will be terminated from the study. Also, subjects who develop a medical condition which can affect their mood stability will be terminated from the study. Receives: Drug: Allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Manic Episodes According to the Young Mania Rating Scale
Young Mania Rating Scale is an 11-item, clinician-administered scale to assess severity of manic symptoms before, during and after treatment. Four items are graded on a min. 0 to max. 8 scale (irritability, speech, thought content and disruptive/aggressive behavior) while the remaining 7 items are graded on a min. 0 to max. 4 scale. A score of 0 indicates behavior is absent and score of 4 or 8 indicates the behavior is present and severe.
The change in score between Baseline and the Completion Visit will be reported. Ideally, the two time points will be Baseline and 6 Weeks after Baseline, but if a subject terminates early, the last Young Mania Rating Scale score will be used. The scores from each question are added for a total score ranging from min. 0 to max 60; higher scores indicate greater severity of symptoms. A score of 0-12 indicates the absence of mania or a very mild manic state, a score of 13-20 or higher indicates a mild manic episode, and over 20 indicates a manic state.
Measured: 2 Years
Secondary outcomes (2)
Number of Depressive Episodes Per Patient Visit According to the Hamilton Depression Scale
The Hamilton Depression Rating Scale is a tool used to determine a patient's level of depression before, during, and after treatment. The Hamilton Depression Scale form lists 21 items, but the scoring is based on the first 17 questions. Eight items are scored on a 5-point scale, ranging from 0 (min) = not present to 4 (max) = severe. Nine are scored from 0 (min) to 2 (max). The sum of the scores from the first 17 questions is: 0 (min) to 7 (max) = normal, 8 (min) to 13 (max) = mild depression, 14 (min) to 18 (max) = moderate depression, 19 (min) to 22 (max) = severe depression and ≥ 23=very severe depression. A score of 11 or more indicates a depressive episode in terms of this outcome measure.
Measured: 2 years
Number of Psychiatric Hospitalizations
The number of psychiatric hospitalizations that occur during the study will be compared to the number of hospitalizations that occurred prior to the study.
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 posted11 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: The outpatient area of the department of psychiatry at CSMC closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- West Coast College of Biological Psychiatry Inc
- Responsible party
- Principal investigator, Itai Danovitch, Cedars-Sinai Medical Center
- Investigators
- Itai Danovitch, MD, Study chair, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732251
- Sponsor's protocol ID
- IRB13414
- Status last verified
- Oct 2019
- First submitted
- 7 Aug 2008
- Last updated
- 2 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Naturalistic Study With Allopurinol Augmentation for Prevention of Mania in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00732251
- Acronym / sponsor ID
- IRB13414
- Conditions
- Bipolar Disorder, Mania, Mixed Mania
- Keywords
- Bipolar Disorder, Stable Bipolar Disorder, Mania, Mixed mania, Allopurinol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The outpatient area of the department of psychiatry at CSMC closed.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- West Coast College of Biological Psychiatry Inc
- Study start
- Aug 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Posted 22 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the efficacy of allopurinol as an augmentation agent for the prevention of mania in bipolar disorder patients with currently stable mood.
Detailed description
The purpose of this study is to investigate the efficacy of allopurinol as an augmentation agent for the prevention of mania in bipolar disorder patients with currently stable mood. Bipolar disorder is a mental disorder with severe mood swings (mania and depression). Despite the development of medications for mania, they may have significant side effects, high costs and the need for serum level monitoring. These factors adversely affect medication compliance in bipolar patients. One recent study indicated the efficacy of allopurinol in the treatment of bipolar mania. Our hypothesis is that the addition of allopurinol to standard medications for bipolar disorder will decrease the recurrences of manic episodes compared to standard medications.
This study will recruit bipolar disorder patients currently mood stable on a therapeutic dose of an anti-manic medication. Stable mood will be defined as a Young Mania Rating Scale score ≤10 and Hamilton Depression Rating Scale ≤10. Subjects must have a diagnosis of bipolar disorder confirmed by the Mini International Neuropsychiatric Interview. Young Mania Rating Scale and Mini International Neuropsychiatric Interview are common research questionnaires used in bipolar disorder studies. Potential subjects will be identified and approached during an outpatient clinical visit by a member of the research team and identified by their treating physicians and referred to the researchers.
This study involves adding allopurinol to subjects' current bipolar medications. This study will be a open label, naturalistic study. The subject will be examined monthly for manic symptoms for 2 years. Semi-structured interviews and study questionnaires will be administered to subjects at each visit. Monthly Follow-up Study Visits (once per month for 2 years - Months 1-5, 7-11, 13-17, 19-23) may be conducted either in-person or over the phone. All of the questionnaires will be administered by a clinician if the visit is completed over the phone. However, the 6-month interval visits (Months 6, 12, 18, and 24) must be done at the research center.
The primary outcome measure will be the number of manic episodes in the 2 year study period. A manic episode will be defined by a Young Mania Rating Scale score ≥20.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allopurinol | Experimental | Drug: AllopurinolUsing an open label, naturalistic design, subjects will continue with their current psychiatric medications during the study. Allopurinol will be given at a fixed dose of 300 mg/day for the first week and then 600mg/d for the remainder of the study. Subjects who cannot tolerate the 600mg dose will be given a dose of 300mg/d. Subjects will participate in monthly follow up visits for 24 months. Subjects who develop a substance abuse or substance dependence disorder during the study will be terminated from the study. Also, subjects who develop a medical condition which can affect their mood stability will be terminated from the study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects must be between ages 18 and 70.
- Subjects must meet diagnostic and statistical manual of mental disorders 4th edition criteria for bipolar disorder confirmed by the Mini International Neuropsychiatric Interview.
- Subjects must be taking at least one medication for mania at a therapeutic dose for at least 2 weeks.
- Subjects must have been diagnosed with bipolar disorder, type 1, for at least 2 years prior to baseline.
- Subjects must have adequate response to medications as evidenced by Young Mania Rating Scale score less than or equal to 10 at screening and at baseline.
Key exclusion criteria (11 listed)
- Subjects who are unable to provide informed consent.
- Subjects with a serious, unstable medical illness (such as cardiovascular, respiratory, neurologic, hematologic, renal, hepatic, endocrine, immunologic, or other systemic illness), a history of cerebrovascular disease, uncontrolled diabetes mellitus or acquired immunodeficiency syndrome (AIDS). Subjects with chronic illness must be stable and otherwise physically healthy on the basis of a physical examination, medical history, electrocardiogram and the results of blood biochemistry, hematology tests and a urinalysis.
- Subjects who develop a medical condition during participation which can affect mood stability (i.e. seizure disorder, brain tumors, brain trauma, stroke, multiple sclerosis, etc.)
- Subjects who develop substance abuse or dependence during participation in the study.
- Subjects taking azathioprine, mercaptopurine, apalcillin, and/or amoxicillin.
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 |
|---|---|---|
| AllopurinolAlso: Zyloprim, AloprimAllopurinol: 300-600 mg/day over a 24 month period | Drug | Allopurinol |
Primary outcome
Number of Manic Episodes According to the Young Mania Rating Scale
Time frame: 2 Years
Young Mania Rating Scale is an 11-item, clinician-administered scale to assess severity of manic symptoms before, during and after treatment. Four items are graded on a min. 0 to max. 8 scale (irritability, speech, thought content and disruptive/aggressive behavior) while the remaining 7 items are graded on a min. 0 to max. 4 scale. A score of 0 indicates behavior is absent and score of 4 or 8 indicates the behavior is present and severe. The change in score between Baseline and the Completion Visit will be reported. Ideally, the two time points will be Baseline and 6 Weeks after Baseline, but if a subject terminates early, the last Young Mania Rating Scale score will be used. The scores from each question are added for a total score ranging from min. 0 to max 60; higher scores indicate greater severity of symptoms. A score of 0-12 indicates the absence of mania or a very mild manic state, a score of 13-20 or higher indicates a mild manic episode, and over 20 indicates a manic state.
2 secondary outcomes
Number of Depressive Episodes Per Patient Visit According to the Hamilton Depression Scale
Time frame: 2 years
Number of Psychiatric Hospitalizations
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Cedars-Sinai Medical Center WebsiteLink provided by the sponsor.
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
RecruitingPhase 4
Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
Depression, Bipolar
Active, not recruiting
Functional Remediation for Older Adults With Bipolar Disorder
Bipolar Disorder
Recruiting
HD-tDCS for Adolescent Bipolar Depression Targeting S1
Adolescent, Bipolar Depression
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.
Itai Danovitch, MD study chair
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Allopurinol in people with Bipolar Disorder and Mania, run by Cedars-Sinai Medical Center 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 12 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: stopped early, as of the sponsor's last update on 2 Oct 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Manic Episodes According to the Young Mania Rating Scale (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 2 Oct 2019.