Bipolar DisorderPhase 3NCT00422331
Safety and Efficacy Study of Lithium in Bipolar Disorder
A Phase 3 study testing Lithium Carbonate Capsule in people with Bipolar Disorder and Mania, run by JDS Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Lithium is safe and effective in the treatment of Bipolar I Disorder subjects with symptoms of acute mania. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Mania
- What is being tested?
- Lithium Carbonate Capsule
- Type of treatment
- Pill or oral medicine
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2007
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Bipolar 1 Disorder;
- Hospitalized or in the process of being hospitalized for a manic or mixed episode
Who cannot join
- History of rapid cycling;
- History of hypersensitivity or adverse reaction to lithium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Lithium in Bipolar I Disorder
The purpose of this study is to determine whether Lithium is safe and effective in the treatment of Bipolar I Disorder subjects with symptoms of acute mania.
- Conditions
- Bipolar Disorder, Mania
- Being tested
- Lithium Carbonate Capsule
- Keywords
- Bipolar I Disorder, Bipolar Disorder, Lithium
- 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.
Lithium Carbonate CapsuleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in YMRS score
Secondary outcomes (2)
change from baseline in CGI-BP score
change from baseline in MADRS score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2007 (estimated)
- Study startJan 2007
- Study completionDec 2007 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JDS Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422331
- Sponsor's protocol ID
- JDS04004
- Other IDs
- Lithium TEAM-1 Study
- Status last verified
- Aug 2007
- First submitted
- 11 Jan 2007
- Last updated
- 14 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Lithium in Bipolar I Disorder
- ClinicalTrials.gov ID
- NCT00422331
- Acronym / sponsor ID
- JDS04004
- Conditions
- Bipolar Disorder, Mania
- Keywords
- Bipolar I Disorder, Bipolar Disorder, Lithium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- JDS PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Study completion
- Dec 2007 (estimated)
- First posted
- 15 Jan 2007 (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 purpose of this study is to determine whether Lithium is safe and effective in the treatment of Bipolar I Disorder subjects with symptoms of acute mania.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Bipolar 1 Disorder;
- Hospitalized or in the process of being hospitalized for a manic or mixed episode
Key exclusion criteria (2 listed)
- History of rapid cycling;
- History of hypersensitivity or adverse reaction to 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 |
|---|---|---|
| Lithium Carbonate Capsule | Drug | – |
Primary outcome
change from baseline in YMRS score
2 secondary outcomes
change from baseline in CGI-BP score
change from baseline in MADRS score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2007.
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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 3 study testing Lithium Carbonate Capsule in people with Bipolar Disorder and Mania, run by JDS Pharmaceuticals 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Aug 2007. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 YMRS score. 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 14 Aug 2007.