Bipolar DisorderPhase 4NCT01543724
Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder
A Phase 4 study testing Lithium in people with Bipolar Disorder, run by Ewha Womans University at 1 site in South Korea.
Trial summary
The investigators will assess Li-induced gray matter volume changes with regard to the endophenotype of GSK3beta polymorphism. The changes of gray matter are supposed to be more attributable to neurotrophic and neuroprotective characteristics of Li, which were closely related to the inhibition of apoptotic activity of… Read more about this study
- Who is it for?
- Ages 19 to 55 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Lithium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2015to 31 Dec 2017
- Phase
- Phase 4
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and Women aged between 19 and 55
- Diagnosis of bipolar I disorder as assessed by the structured clinical interview for DSM-IV (SCID-IV)
- Patients who have not used psychoactive medications for more than 2 weeks
- Individuals who provided written consent for participation
Who cannot join
- Presence of any major physical or neurological illness (e.g., head trauma, epilepsy, seizure, stroke, cerebral tumor, multiple sclerosis, cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity, etc.)
- Women who are pregnant, breastfeeding, or planning pregnancy
- Diagnosis of any Axis I disorder other than bipolar disorder
- Intelligence quotient below 80
- Current or past drug abuse
- Contraindications to magnetic resonance imaging (e.g., pacemaker implantation, claustrophobia, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multimodal Brain Imaging Study to Investigate Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder: Glycogen Synthase Kinase 3β Single Nucleotide Polymorphisms and Gray Matter Volume Increase Following Lithium Treatment in Bipolar Disorder
The investigators will assess Li-induced gray matter volume changes with regard to the endophenotype of GSK3beta polymorphism. The changes of gray matter are supposed to be more attributable to neurotrophic and neuroprotective characteristics of Li, which were closely related to the inhibition of apoptotic activity of GSK3beta.
- Conditions
- Bipolar Disorder
- Being tested
- Lithium
- Keywords
- Lithium, Bipolar disorder, Multimodal Brain Imaging
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LithiumDrug
10mg/kg/day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lithium | Experimental | Not described Receives: Drug: Lithium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in manic symptom scores at 12 weeks
Measured: Baseline and at 12 weeks
Change from baseline in manic symptom scores at 8 weeks
Measured: Baseline and at 8 weeks
Change from baseline in manic symptom scores at 4 weeks
Measured: Baseline and at 4 weeks
Change from baseline in manic symptom scores at 1 week
Measured: Baseline and at 1 week
Change from baseline in depressive symptom scores at 12 weeks
Measured: Baseline and at 12 weeks
Change from baseline in depressive symptom scores at 8 weeks
Measured: Baseline and at 8 weeks
Change from baseline in depressive symptom scores at 4 weeks
Measured: Baseline and at 4 weeks
Change from baseline in depressive symptom scores at 1 week
Measured: Baseline and at 1 week
Change from baseline in global function scores at 12 weeks
Measured: Baseline and at 12 weeks
Change from baseline in global function scores at 8 weeks
Measured: Baseline and at 8 weeks
Change from baseline in global function scores at 4 weeks
Measured: Baseline and at 4 weeks
Change from baseline in global function scores at 1 week
Measured: Baseline and at 1 week
Secondary outcomes (5)
Changes from baseline in brain structure analyzed using computational approach
Measured: Baseline and at 12 weeks
Number of participants with adverse events
Measured: 12 weeks
Number of participants with adverse events
Measured: 8 weeks
Number of participants with adverse events
Measured: 4 weeks
Number of participants with adverse events
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study start1 Jun 2015 (estimated)
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Why it stopped: The research project has been cancelled before any participants were enrolled.
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.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Collaborators
- Soon Chun Hyang University
- Responsible party
- Principal investigator, In Kyoon Lyoo, Ewha Womans University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543724
- Sponsor's protocol ID
- bpli2008
- Status last verified
- Feb 2018
- First submitted
- 28 Feb 2012
- Last updated
- 9 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Brain Imaging Study to Investigate Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder: Glycogen Synthase Kinase 3β Single Nucleotide Polymorphisms and Gray Matter Volume Increase Following Lithium Treatment in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT01543724
- Acronym / sponsor ID
- bpli2008
- Conditions
- Bipolar Disorder
- Keywords
- Lithium, Bipolar disorder, Multimodal Brain Imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The research project has been cancelled before any participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Collaborators
- Soon Chun Hyang University
- Study start
- 1 Jun 2015 (estimated)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 5 Mar 2012 (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 investigators will assess Li-induced gray matter volume changes with regard to the endophenotype of GSK3beta polymorphism. The changes of gray matter are supposed to be more attributable to neurotrophic and neuroprotective characteristics of Li, which were closely related to the inhibition of apoptotic activity of GSK3beta.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lithium | Experimental | Drug: Lithium |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and Women aged between 19 and 55
- Diagnosis of bipolar I disorder as assessed by the structured clinical interview for DSM-IV (SCID-IV)
- Patients who have not used psychoactive medications for more than 2 weeks
- Individuals who provided written consent for participation
Key exclusion criteria (6 listed)
- Presence of any major physical or neurological illness (e.g., head trauma, epilepsy, seizure, stroke, cerebral tumor, multiple sclerosis, cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity, etc.)
- Women who are pregnant, breastfeeding, or planning pregnancy
- Diagnosis of any Axis I disorder other than bipolar disorder
- Intelligence quotient below 80
- Current or past drug abuse
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 |
|---|---|---|
| Lithium10mg/kg/day for 12 weeks | Drug | Lithium |
Primary outcome
Change from baseline in manic symptom scores at 12 weeks
Time frame: Baseline and at 12 weeks
Change from baseline in manic symptom scores at 8 weeks
Time frame: Baseline and at 8 weeks
Change from baseline in manic symptom scores at 4 weeks
Time frame: Baseline and at 4 weeks
Change from baseline in manic symptom scores at 1 week
Time frame: Baseline and at 1 week
Change from baseline in depressive symptom scores at 12 weeks
Time frame: Baseline and at 12 weeks
Change from baseline in depressive symptom scores at 8 weeks
Time frame: Baseline and at 8 weeks
Change from baseline in depressive symptom scores at 4 weeks
Time frame: Baseline and at 4 weeks
Change from baseline in depressive symptom scores at 1 week
Time frame: Baseline and at 1 week
Change from baseline in global function scores at 12 weeks
Time frame: Baseline and at 12 weeks
Change from baseline in global function scores at 8 weeks
Time frame: Baseline and at 8 weeks
Change from baseline in global function scores at 4 weeks
Time frame: Baseline and at 4 weeks
Change from baseline in global function scores at 1 week
Time frame: Baseline and at 1 week
5 secondary outcomes
Changes from baseline in brain structure analyzed using computational approach
Time frame: Baseline and at 12 weeks
Number of participants with adverse events
Time frame: 12 weeks
Number of participants with adverse events
Time frame: 8 weeks
Number of participants with adverse events
Time frame: 4 weeks
Number of participants with adverse events
Time frame: 1 week
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 9 Feb 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lithium in people with Bipolar Disorder, run by Ewha Womans University at 1 site in South Korea.
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 4 inclusion and 6 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 9 Feb 2018. 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 South Korea. 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?
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?
Change from baseline in manic symptom scores at 12 weeks (time frame: Baseline and at 12 weeks). The study lists 12 primary outcomes in all. 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 9 Feb 2018.