Bipolar DepressionPhase 2NCT00359125
RU-486 in the Treatment of Bipolar Depression
A Phase 2 study testing mifepristone (RU-486) in people with Bipolar Depression, run by University of British Columbia at 1 site in Canada.
Trial summary
Bipolar disorder is a chronic and recurrent illness which involves episodes of mania and depression. It is believed that disturbance of the stress hormone system (the hypothalamic-pituitary-adrenal or HPA axis) may cause thinking and memory problems and make the depressive symptoms worse in bipolar disorder. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- mifepristone (RU-486)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2006to Dec 2010
- Phase
- Phase 2
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male \& female outpatients between 19-65 years of age with a diagnosis of bipolar depression. Women must not be currently pregnant and must use a reliable method of contraception for the duration of the study. Subjects must be on stable medication (4 weeks minimum) for their bipolar illness. Subjects must be able to provide written informed consent. Subjects must adequately understand written \& verbal English as rating scales as neurocognitive tests are only in English.
Who cannot join
- Those not meeting the above criteria and those not competent to give informed consent. Women who are currently pregnant. Also excluded: those who have a clinically significant medical illness (including significant head injury with loss of consciousness), those at immediate risk of harming self or others, are currently abusing alcohol or drugs, those with a neurological disorder or uncompensated endocrine disorder, those with a known allergy to mifepristone, those currently being treated with an investigational medication or medication that is contraindicated with mifepristone.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia, Dept. of Psychiatry
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: Efficacy of Mifepristone (RU-486) in the Treatment of Bipolar Depression.
Bipolar disorder is a chronic and recurrent illness which involves episodes of mania and depression. It is believed that disturbance of the stress hormone system (the hypothalamic-pituitary-adrenal or HPA axis) may cause thinking and memory problems and make the depressive symptoms worse in bipolar disorder. Early studies have shown that mifepristone may have antidepressant effects (may improve the symptoms of depression) and may also maintain or enhance cognition (memory and thinking functions).
The purpose of this study is to determine the potential therapeutic efficacy (usefulness) of mifepristone in bipolar depression by assessing the effects of the medication on depressive symptoms and on cognition. This will be done by questionnaires and thinking tests.
This study will also try to clarify the functional changes that accompany bipolar disorder by analyzing saliva samples (assessing the stress response by measuring the levels of 2 stress hormones: cortisol and DHEA).
Read the detailed description
Detailed Description:
This study will be a parallel design randomized control trial. Duration of study is 10 weeks per subject. Following a baseline assessment of neurocognitive performance, mood symptoms, and neuroendocrine functioning (HPA axis functioning), bipolar depressed outpatients (n=100) will be randomized (week 0) to receive either mifepristone 600 mg daily (n=50) or matching placebo (n=50) for 7 days. Outcome measures will be completed at baseline (pre-medication), at the time of anticipated main response (week 3, i.e. 2 weeks after cessation of treatment), and at week 8 (to determine the persistence of any effects).
Neurocognitive performance (pre and post mifepristone treatment) will be evaluated with tests that have previously been shown to be affected by corticosteroids and to be abnormal in bipolar disorder. The neurocognitive battery will measure learning and memory, attention, executive functioning, and facial expression (which has been shown to be a sensitive measure of affective shift).
Mood symptoms will be evaluated at every study visit using standard clinician and patient self-rated scales.
Neuroendocrine functioning (HPA axis functioning) will be measured by the dexamethasone suppression test (DST) response to dexamethasone. This is a measure of the function of the glucocorticoid receptor. Subjects will also be asked for salivary samples to measure the cortisol response to wakening and the ratio of cortisol to the protective steroid DHEA. These validated tests will be used to improve our understanding of the mechanism of the therapeutic effect of mifepristone.
Fifty (50) matched-healthy controls will also undergo the baseline assessments of neurocognitive performance, mood symptoms, and neuroendocrine functioning. They will provide information about the pathophysiology of bipolar disorder.
- Conditions
- Bipolar Depression
- Being tested
- mifepristone (RU-486), Placebo
- Keywords
- bipolar, RU-486, mifepristone, neurocognition, mood, cortisol, HPA axis
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mifepristone (RU-486)Drug
Also called Mifepristone
RU-486, 600 mg/day for 1 week.
PlaceboOther
Placebo, 600 mg/day for 1 week.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | RU-486, 600 mg/day for 1 week. Receives: Drug: mifepristone (RU-486) |
| 2 | Placebo comparator | Placebo, 600 mg/day for 1 week Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive performance at weeks -1, 3 & 8 and symptom change at weeks -2, -1, 0, 1, 2, 3, 4, 5 & 8
Secondary outcomes (1)
HPA axis functioning from saliva samples at weeks -2, -1, 2, 3 & 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Western Economic Diversification Canada, Stanley Medical Research Institute
- Investigators
- Allan Young, MD, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359125
- Sponsor's protocol ID
- C06-0327
- Other IDs
- H06-0093
- Status last verified
- Jan 2014
- First submitted
- 28 Jul 2006
- Last updated
- 22 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mifepristone (RU-486) in the Treatment of Bipolar Depression.
- ClinicalTrials.gov ID
- NCT00359125
- Acronym / sponsor ID
- C06-0327
- Conditions
- Bipolar Depression
- Keywords
- bipolar, RU-486, mifepristone, neurocognition, mood, cortisol, HPA axis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Western Economic Diversification Canada, Stanley Medical Research Institute
- Study start
- Jul 2006
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 1 Aug 2006 (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.
Bipolar disorder is a chronic and recurrent illness which involves episodes of mania and depression. It is believed that disturbance of the stress hormone system (the hypothalamic-pituitary-adrenal or HPA axis) may cause thinking and memory problems and make the depressive symptoms worse in bipolar disorder. Early studies have shown that mifepristone may have antidepressant effects (may improve the symptoms of depression) and may also maintain or enhance cognition (memory and thinking functions).
The purpose of this study is to determine the potential therapeutic efficacy (usefulness) of mifepristone in bipolar depression by assessing the effects of the medication on depressive symptoms and on cognition. This will be done by questionnaires and thinking tests.
This study will also try to clarify the functional changes that accompany bipolar disorder by analyzing saliva samples (assessing the stress response by measuring the levels of 2 stress hormones: cortisol and DHEA).
Detailed description
Detailed Description:
This study will be a parallel design randomized control trial. Duration of study is 10 weeks per subject. Following a baseline assessment of neurocognitive performance, mood symptoms, and neuroendocrine functioning (HPA axis functioning), bipolar depressed outpatients (n=100) will be randomized (week 0) to receive either mifepristone 600 mg daily (n=50) or matching placebo (n=50) for 7 days. Outcome measures will be completed at baseline (pre-medication), at the time of anticipated main response (week 3, i.e. 2 weeks after cessation of treatment), and at week 8 (to determine the persistence of any effects).
Neurocognitive performance (pre and post mifepristone treatment) will be evaluated with tests that have previously been shown to be affected by corticosteroids and to be abnormal in bipolar disorder. The neurocognitive battery will measure learning and memory, attention, executive functioning, and facial expression (which has been shown to be a sensitive measure of affective shift).
Mood symptoms will be evaluated at every study visit using standard clinician and patient self-rated scales.
Neuroendocrine functioning (HPA axis functioning) will be measured by the dexamethasone suppression test (DST) response to dexamethasone. This is a measure of the function of the glucocorticoid receptor. Subjects will also be asked for salivary samples to measure the cortisol response to wakening and the ratio of cortisol to the protective steroid DHEA. These validated tests will be used to improve our understanding of the mechanism of the therapeutic effect of mifepristone.
Fifty (50) matched-healthy controls will also undergo the baseline assessments of neurocognitive performance, mood symptoms, and neuroendocrine functioning. They will provide information about the pathophysiology of bipolar disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: mifepristone (RU-486)RU-486, 600 mg/day for 1 week. |
| 2 | Placebo comparator | Other: PlaceboPlacebo, 600 mg/day for 1 week |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male \& female outpatients between 19-65 years of age with a diagnosis of bipolar depression. Women must not be currently pregnant and must use a reliable method of contraception for the duration of the study. Subjects must be on stable medication (4 weeks minimum) for their bipolar illness. Subjects must be able to provide written informed consent. Subjects must adequately understand written \& verbal English as rating scales as neurocognitive tests are only in English.
Key exclusion criteria (1 listed)
- Those not meeting the above criteria and those not competent to give informed consent. Women who are currently pregnant. Also excluded: those who have a clinically significant medical illness (including significant head injury with loss of consciousness), those at immediate risk of harming self or others, are currently abusing alcohol or drugs, those with a neurological disorder or uncompensated endocrine disorder, those with a known allergy to mifepristone, those currently being treated with an investigational medication or medication that is contraindicated with mifepristone.
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 |
|---|---|---|
| mifepristone (RU-486)Also: MifepristoneRU-486, 600 mg/day for 1 week. | Drug | 1 |
| PlaceboPlacebo, 600 mg/day for 1 week. | Other | 2 |
Primary outcome
Neurocognitive performance at weeks -1, 3 & 8 and symptom change at weeks -2, -1, 0, 1, 2, 3, 4, 5 & 8
1 secondary outcome
HPA axis functioning from saliva samples at weeks -2, -1, 2, 3 & 8
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 22 Jan 2014.
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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.
Allan Young, MD principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mifepristone (RU-486) in people with Bipolar Depression, run by University of British Columbia at 1 site in Canada.
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 1 inclusion and 1 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 22 Jan 2014. 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 Canada. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Neurocognitive performance at weeks -1, 3 & 8 and symptom change at weeks -2, -1, 0, 1, 2, 3, 4, 5 & 8. 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 22 Jan 2014.