Bipolar DisorderPhase 1NCT00321516
Drug-drug Interaction Study of Aripiprazole and Lamotrigine in Patients With Bipolar Type I Disorder
A Phase 1 study testing aripiprazole in people with Bipolar Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 4 sites in United States.
Trial summary
The purpose of this clinical research study is to learn if aripiprazole has a drug-drug interaction with lamotrigine. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2006to Feb 2007
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) of 18 to 40 kg/m2
- Subjects with bipolar I disorder who are clinically stable on a stable dose of at least 100 mg lamotrigine for at least 4 weeks prior to study entry
- Men and women, ages 18 to 65
Who cannot join
- Women who are pregnant or breastfeeding
- Patients with any significant acute or chronic medical illness, other than bipolar I disorder
- Subjects with active psychotic symptoms
- History of head trauma within the past 2 years
- History of akathisia requiring treatment
- History of tardive dyskinesia or abnormal involuntary movements
Show all 9Show fewer
- Subjects with a predisposition to orthostatic hypotension
- Positive urine screen for drugs of abuse
- Use of narcotic-containing agents, amphetamines, or hormonal contraceptives within 4 weeks of study start
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Local Institution
Austin, Texas
Local Institution
Bellaire, Texas
Local Institution
Desota, Texas
Local Institution
Philadelphia, Pennsylvania
About this study
Official title: Effects of Aripiprazole on the Steady-State Pharmacokinetics of Lamotrigine in Subjects With Bipolar I Disorder
The purpose of this clinical research study is to learn if aripiprazole has a drug-drug interaction with lamotrigine.
- Conditions
- Bipolar Disorder
- Being tested
- aripiprazole
- Keywords
- Bipolar type I Disorder
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aripiprazoleDrug
Also called Abilify
Tablets, Oral, 10, 20, or 30 mg (titrated), once daily, 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Cmax (maximum drug concentration) and AUC(Tau) (exposure) of lamotrigine at the beginning of the study (Day-1) and when the subject completes the study (Day 36)
Secondary outcomes (1)
Assess the safety and tolerability of aripiprazole when co-administered with lamotrigine for up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startJul 2006
- Primary completionFeb 2007
- Study completionFeb 2007
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.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The 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 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321516
- Sponsor's protocol ID
- CN138-402
- Other IDs
- IND #: 42,776
- Status last verified
- Jun 2008
- First submitted
- 1 May 2006
- Last updated
- 8 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aripiprazole on the Steady-State Pharmacokinetics of Lamotrigine in Subjects With Bipolar I Disorder
- ClinicalTrials.gov ID
- NCT00321516
- Acronym / sponsor ID
- CN138-402
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar type I Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 3 May 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.
The purpose of this clinical research study is to learn if aripiprazole has a drug-drug interaction with lamotrigine.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: aripiprazole |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) of 18 to 40 kg/m2
- Subjects with bipolar I disorder who are clinically stable on a stable dose of at least 100 mg lamotrigine for at least 4 weeks prior to study entry
- Men and women, ages 18 to 65
Key exclusion criteria (9 listed)
- Women who are pregnant or breastfeeding
- Patients with any significant acute or chronic medical illness, other than bipolar I disorder
- Subjects with active psychotic symptoms
- History of head trauma within the past 2 years
- History of akathisia requiring treatment
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 |
|---|---|---|
| aripiprazoleAlso: AbilifyTablets, Oral, 10, 20, or 30 mg (titrated), once daily, 14 days. | Drug | 1 |
Primary outcome
Comparison of Cmax (maximum drug concentration) and AUC(Tau) (exposure) of lamotrigine at the beginning of the study (Day-1) and when the subject completes the study (Day 36)
1 secondary outcome
Assess the safety and tolerability of aripiprazole when co-administered with lamotrigine for up to 4 weeks
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 8 Nov 2013.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing aripiprazole in people with Bipolar Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 4 sites 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 3 inclusion and 9 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 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Comparison of Cmax (maximum drug concentration) and AUC(Tau) (exposure) of lamotrigine at the beginning of the study (Day-1) and when the subject completes the study (Day 36). 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 8 Nov 2013.