Bipolar I DisorderPhase 3NCT00606229

A Multicenter Investigative Study of the Safety and Efficacy of Long-term Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

A Phase 3 study testing Aripiprazole in people with Bipolar I Disorder, run by Otsuka Pharmaceutical Co., Ltd. at 5 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To assess the safety and efficacy of long-term administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner in patients with Bipolar I Disorder experiencing a manic or mixed episode Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Bipolar I 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: 41 participants
Where: 5 sitesJapan
Study dates: Jan 2008to Nov 2010
Phase: Phase 3
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Trial subjects will be men and women of age 18 or above and below the age of 65 who will not be turning 65 during the trial.
Patients have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial.
Patients who meet DSM-IV-TR criteria for manic or mixed episodes and have been diagnosed as having "296.4x Bipolar I Disorder in which the most recent episode was manic" or "296.6x Bipolar I Disorder in which the most recent episode was mixed"
Patients with a YMRS total score of 16 or more

Who cannot join

Patients presenting with a clinical picture and/or history that is consistent with a DSM-IV-TR diagnosis of:
Delirium, dementia, amnestic disorder, or other cognitive disorders
Schizophrenia or other psychotic disorder
Personality disorder
Patients experiencing their first manic or mixed episode
Patients whose current manic episode has lasted for more than 4 weeks

Show all 24Show fewer

Patients with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance
Patients who have met DSM-IV-TR criteria for a substance-related disorder within 3 months (90 days) prior to informed consent (excluding caffeine- and nicotine-related disorders, but including abuse of benzodiazepines)
Patients who have received ECT treatment within 8 weeks prior to informed consent
Patients who are expected to require administration of ultrashort-acting or short-acting benzodiazepine receptor agonist hypnotics and antianxiety drugs (See (1) of 4.2.2) at doses exceeding the equivalent of 15 mg/day of diazepam (Only for those patients using such drugs)
Patients at significant risk of developing a severe adverse event. Patients who have a medical condition that would interfere with assessments of safety or efficacy during the course of the trial, or who have a history of such a condition.
Patients who have received any of the following treatments during the screening period
Reserpine
Levodopa, dopamine receptor stimulants
Monoamine oxidase inhibitors
Psychostimulants
Thyroid hormones, antithyroid drugs
Corticosteroids (other than topical preparations)
Adrenaline
All other investigational or unapproved agents
ECT
Light therapy
Patients judged to have a diabetic blood glucose level (judgment based on use of a self-monitoring blood glucose meter permissible), or patients whose HbA1c is 6.5% or higher
Patients with a history or a complication of diabetes

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Japan5 sites

Study site
Chugoku Region
Study site
Hokuriku Region
Study site
Kanto Region
Study site
Kinki Region
Study site
Shikoku Region

Other trials in Japan

About this study

Conditions: Bipolar I Disorder
Being tested: Aripiprazole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AripiprazoleDrug
Also called OPC-14597
oral, 24mg/day

Study groups in NCT00606229
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.

Young Mania Rating Scale (YMRS)
Mean change from baseline (Day 1) to endpoint in the YMRS total score
YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) elevated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior.
Total score range is 0 to 60, and the higher value represents worsen.
Measured: Day 1 and Day 168 or time of discontinuation

Secondary outcomes (1)

Clinical Global Impression - Bipolar Version (CGI-BP) Sevirity of Illness Score (Mania)
Mean change from baseline (Day 1) to endpoint in Clinical Global Impression -Bipolar Version (CGI-BP) severity of illness score (mania)
The severity of manic symptoms on a scale of 1 (normal, not ill) to 7 (very severely ill)
Measured: Day 1 and Daty 168 or time of discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Nov 2010

First posted1 Feb 2008 (estimated)
Study startJan 2008
Primary completionNov 2010
Study completionNov 2010

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 I DisorderStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00606229
Sponsor's protocol ID: 031-07-001
Status last verified: Feb 2014
First submitted: 19 Jan 2008
Last updated: 13 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bipolar I Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Investigative Study of the Safety and Efficacy of Long-term Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
ClinicalTrials.gov ID: NCT00606229
Acronym / sponsor ID: 031-07-001
Conditions: Bipolar I Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 1 Feb 2008 (estimated)
Results: Posted 13 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: 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: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Trial subjects will be men and women of age 18 or above and below the age of 65 who will not be turning 65 during the trial.
Patients have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial.
Patients who meet DSM-IV-TR criteria for manic or mixed episodes and have been diagnosed as having "296.4x Bipolar I Disorder in which the most recent episode was manic" or "296.6x Bipolar I Disorder in which the most recent episode was mixed"
Patients with a YMRS total score of 16 or more

Key exclusion criteria (24 listed)

Patients presenting with a clinical picture and/or history that is consistent with a DSM-IV-TR diagnosis of:
Patients experiencing their first manic or mixed episode
Patients whose current manic episode has lasted for more than 4 weeks
Patients with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance
Patients who have met DSM-IV-TR criteria for a substance-related disorder within 3 months (90 days) prior to informed consent (excluding caffeine- and nicotine-related disorders, but including abuse of benzodiazepines)

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: OPC-14597oral, 24mg/day	Drug	1

Primary outcome

Young Mania Rating Scale (YMRS)
Time frame: Day 1 and Day 168 or time of discontinuation
Mean change from baseline (Day 1) to endpoint in the YMRS total score YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) elevated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior. Total score range is 0 to 60, and the higher value represents worsen.

1 secondary outcome

Clinical Global Impression - Bipolar Version (CGI-BP) Sevirity of Illness Score (Mania)
Time frame: Day 1 and Daty 168 or time of discontinuation

Results and safety

Results posted to the registry on 13 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aripiprazole	41	19

Primary outcome: Young Mania Rating Scale (YMRS)

Time frame: Day 1 and Day 168 or time of discontinuation. Mean (Standard Deviation). Unit: scores on a scale

Measure	Aripiprazole n = 40
Value	-18.8 (9.86)

Population analysed: Results obtained from the LOCF dataset of 40 subjects of the Full Analysis Set (FAS) (excluding 1 subject whose post-dose data of efficacy endpoint were not available from the 41 treated subjects)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aripiprazole	4 of 41 (9.8%)	35 of 41 (85.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Katsuhisa Saito study director

Department of Clinical Research and Development, Division of New Product Evaluation and Development

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aripiprazole in people with Bipolar I Disorder, run by Otsuka Pharmaceutical Co., Ltd. at 5 sites in Japan.

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 24 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 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan. 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?

Yes. Results are posted in the registry (first posted 13 Mar 2014). 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?

Young Mania Rating Scale (YMRS) (time frame: Day 1 and Day 168 or time of discontinuation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00606229.

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 13 Mar 2014.