Bipolar Disorder ManiaPhase 3NCT00665366
Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder
A Phase 3 study testing Aripiprazole, Lithium and Valproate in people with Bipolar Disorder Mania, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 73 sites in 13 countries.
Trial summary
The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder Mania
- What is being tested?
- Aripiprazole, Lithium and Valproate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 493 participants
- Where
- 73 sitesin 13 countries
- Study dates
- Jun 2008to Oct 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of bipolar I disorder mania, manic or mixed episode, with or without psychotic features
- Current ongoing lithium or valproate treatment with the possibility of benefiting, based on the investigator's clinical judgment, from adjunctive treatment with aripiprazole
- Therapeutic serum levels of lithium or valproate and a Young Mania Rating Total Score of 16 or higher at screening and baseline
- Participants taking current lithium or valproate treatment combined with antipsychotic medication other than aripiprazole are acceptable, provided that the other antipsychotic medication is washed out at least 3 days prior to the blood draw for therapeutic plasma levels of lithium and valproate determination. Long-acting antipsychotics must be washed out prior to entering the double-blind treatment.
Who cannot join
- Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of investigational product
- A diagnosis of delirium, dementia, amnesia or other cognitive disorder, or a psychotic disorder
- Current diagnosis of delirium, dementia, a cognitive disorder (ie, amnesia), or a psychotic disorder (ie, schizophrenia or schizoaffective disorder)
- Current diagnosis of bipolar II disorder, bipolar disorder not otherwise specified, or any other primary psychiatric disorder other than bipolar I disorder mania
- Thyroid pathology
- Demonstrated cocaine abuse or dependence within the past 3 months prior to screening.
Show all 10Show fewer
- History of neuroleptic malignant syndrome from antipsychotic agents
- Manic symptoms that investigator considers refractory to treatment
- Previous nonresponsive (by investigator judgment) to aripiprazole for manic symptoms
- Significant risk of suicide based on history, mental status exam, or investigator judgment.
Trial locations and contacts
73 sites in 13 countries.
73 sites in 13 countries
France15 sites
Local Institution
Beaupuy, 31850
Local Institution
Brumath, 67173
Local Institution
Château-Gontier, 53200
Local Institution
Clermont-Ferrand, 63001
Local Institution
Dijon, 21000
Local Institution
Dole, 39100
Local Institution
Jonzac, 175003
Local Institution
Le Vésinet, 78110
Local Institution
Montpellier, 34295
Local Institution
Nîmes, 30900
Local Institution
Paris, 75116
Local Institution
Reims, 51092
Local Institution
Saint-Nazaire, 44606
Local Institution
Sotteville-lès-Rouen, 76300
Local Institution
Strasbourg, 67091
Italy11 sites
Local Institution
Campobasso, 86100
Local Institution
Foggia, 71100
Local Institution
Foligno (Pg), 06034
Local Institution
Genova, 16132
Local Institution
La Spezia, 19124
Local Institution
Milan, 20121
Local Institution
Naples, 80131
Local Institution
Pisa, 56126
Local Institution
Roma, 00168
Local Institution
Roma, 00189
Local Institution
Sant'Arsenio (Salerno), 84037
Russia8 sites
Local Institution
Khot'kovo, 141371
Local Institution
Krasnodar, 350087
Local Institution
Moscow, 115522
Local Institution
Moscow, 119992
Local Institution
Rostov-on-Don, 344010
Local Institution
Saint Petersburg, 192019
Local Institution
Samara, 443016
Local Institution
Tomsk, 634014
Hungary6 sites
Local Institution
Budapest, 1083
Local Institution
Budapest, 1097
Local Institution
Budapest, 1125
Local Institution
Budapest, 1135
Local Institution
Győr, 9024
Local Institution
Gyula, 5700
Poland6 sites
Local Institution
Choroszcz, 16070
Local Institution
Gdansk, 80-952
Local Institution
Krakow, 30-393
Local Institution
Krakow, 31-501
Local Institution
Poznan, 60-572
Local Institution
Swiecie N/Wisla, 86-100
Czechia5 sites
Local Institution
Hradec Králové, 500 05
Local Institution
Litoměřice, 41201
Local Institution
Prague, 101 00
Local Institution
Prague, 120 00
Local Institution
Prague, 160 00
South Africa5 sites
Local Institution
Cape Town, Western Cape, 7530
Local Institution
Johannesburg, Gauteng, 2198
Local Institution
Pinetown, KwaZulu-Natal, 3600
Local Institution
Soweto, Gauteng, 2001
Local Institution
Vereeniging, Gauteng, 1939
Greece4 sites
Local Institution
Athens, 151 26
Local Institution
Leros, 85400
Local Institution
Nea Ionia-Athens, 14233
Local Institution
Tripoli, 22100
Romania3 sites
Local Institution
Bucharest, 041915
Local Institution
Cluj-Nappoca, 400012
Local Institution
Iași, 700282
Spain3 sites
Local Institution
Barcelona, 08036
Local Institution
Madrid, 28046
Local Institution
Murcia, 30120
Turkey (Türkiye)3 sites
Local Institution
Ankara, 06100
Local Institution
Antalya, 07070
Local Institution
Denizli, 20100
Germany2 sites
Local Institution
Ellwangen, 73479
Local Institution
Ostfildern, 73760
About this study
Official title: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated on Valproate or Lithium and in Need of Further Clinical Improvement
The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.
- Conditions
- Bipolar Disorder Mania
- Being tested
- Aripiprazole, Placebo, Lithium, Valproate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Also called Abilify, BMS-337039
5-, 10-, or 15-mg oral tablets in titrated doses for 12 weeks
PlaceboDrug
Tablets, Oral, 0 mg, once daily, 12 weeks
LithiumDrug
Participant's ongoing dose
ValproateDrug
Participant's ongoing dose
| Study group | Role | What they receive |
|---|---|---|
| Placebo + valproate or lithium | Placebo comparator | Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Receives: Drug: Placebo; Drug: Lithium; Drug: Valproate |
| Aripiprazole + valproate or lithium | Active comparator | Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12. Receives: Drug: Aripiprazole; Drug: Lithium; Drug: Valproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set)
The YMRS is a clinician-administered scale, consisting of 11 multiple choice items, and used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-though disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward.
Measured: Baseline to Week 12
Secondary outcomes (11)
Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set)
Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.
Measured: Baseline to Weeks 3, 6, 9, and 12
Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Depression) Scale (LOCF Data Set)
Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.
Measured: Baseline to Weeks 3, 6, 9, and 12
Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Overall) Scale at Week 12 (LOCF Data Set)
Adjusted mean change. The CGI-BP is scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.
Measured: Baseline to Week 12
Change From Baseline in Total and Subscale Scores on the Functional Assessment Short Test (FAST)(LOCF Data Set)
The FAST is an interview-administered instrument used to assess the main functioning problems that patients with bipolar disorder experience. Participants are rated at Baseline, Week 3, Week 6, Week 9, and Week 12/End of Study Visit. The FAST consists of 24 items that assess impairment or disability in 6 specific areas of functioning, categorized as the subscales: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal (IP) relationships, and leisure time. All items are rated using a 4-point scale, 0=no difficulty, 1=mild difficulty, 2=moderate difficulty, and 3=severe difficulty. The global score is the sum of the scores of all items and ranges from 0 (0*24)to 96 (4*24). The higher the global score, the higher the level of impairment. function=functioning. LOCF=last observation carried forward.
Measured: Baseline to Weeks 3, 6, 9, and 12
Percentage of Participants Showing A Response From Baseline on the Young Mania Rating Scale (YMRS)(OC Data Set)
Response on the YMRS is defined as a 50% or greater improvement from baseline in YMRS total score. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. OC=observed cases.
Measured: Baseline to Weeks 3, 6, 9, and 12
Percentage of Participants Showing Remission in the Young Mania Rating Scale (YMRS) Score From Baseline (LOCF Data Set)
Remission is defined as a YMRS total score of 12 or less. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward.
Measured: Baseline to Weeks 3,6, 9, and 12
Change From Baseline in Total Score on the Longitudinal Interval Follow-up Evaluation-Rating Impaired Functioning Tool (LIFE-RIFT)(OC Data Set and Week 12 LOCF Data Set)
Adjusted mean change. The LIFE-RIFT total score ranges from 4 to 20 and is the sum of scores of 4 items: work, interpersonal relations, satisfaction, and recreation. A negative change score signifies improvement. OC=observed cases; LOCF=last observation carried forward.
Measured: Baseline to Weeks 6 and 12
Participant Scores on Patient Global Impression Improvement (PGI-I) Scale (OC Data Set)
Adjusted Mean Scores. The PGI-I is a self-administered 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention. Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. OC=observed cases.
Measured: Baseline to Weeks 3, 6, 9, and 12
Change From Baseline in Participant Weight (OC Data Set and Week 12 LOCF Data Set)
Adjusted mean change.OC=observed cases; LOCF=last observation carried forward.
Measured: Baseline to Weeks 3, 6, 9, and 12
Percentage of Participants With Relevant Weight Gain or Weight Loss From Baseline at Week 12 (LOCF Data Set)
Relevant weight gain=7% or greater increase in weight; relevant weight loss=7% or greater decrease in weight. LOCF=last observation carried forward.
Measured: Baseline to Weeks 3, 6, 9, and12
Change From Baseline to Week 12 in Body Mass Index (BMI) (LOCF Data Set)
BMI=Weight in kilograms /(Height in meters^2). LOCF=last observation carried forward.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2011
- Study completionOct 2011
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 Disorder ManiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 493 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665366
- Sponsor's protocol ID
- CN138-502
- Other IDs
- EudraCT number 2007-005959-42
- Status last verified
- Feb 2013
- First submitted
- 18 Apr 2008
- Last updated
- 2 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated on Valproate or Lithium and in Need of Further Clinical Improvement
- ClinicalTrials.gov ID
- NCT00665366
- Acronym / sponsor ID
- CN138-502
- Conditions
- Bipolar Disorder Mania
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 493 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Study start
- Jun 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Apr 2008 (estimated)
- Results
- Posted 4 Feb 2013
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 the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo + valproate or lithium | Placebo comparator | Drug: Placebo, Drug: Lithium, Drug: ValproateParticipants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. |
| Aripiprazole + valproate or lithium | Active comparator | Drug: Aripiprazole, Drug: Lithium, Drug: ValproateParticipants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of bipolar I disorder mania, manic or mixed episode, with or without psychotic features
- Current ongoing lithium or valproate treatment with the possibility of benefiting, based on the investigator's clinical judgment, from adjunctive treatment with aripiprazole
- Therapeutic serum levels of lithium or valproate and a Young Mania Rating Total Score of 16 or higher at screening and baseline
- Participants taking current lithium or valproate treatment combined with antipsychotic medication other than aripiprazole are acceptable, provided that the other antipsychotic medication is washed out at least 3 days prior to the blood draw for therapeutic plasma levels of lithium and valproate determination. Long-acting antipsychotics must be washed out prior to entering the double-blind treatment.
Key exclusion criteria (10 listed)
- Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of investigational product
- A diagnosis of delirium, dementia, amnesia or other cognitive disorder, or a psychotic disorder
- Current diagnosis of delirium, dementia, a cognitive disorder (ie, amnesia), or a psychotic disorder (ie, schizophrenia or schizoaffective disorder)
- Current diagnosis of bipolar II disorder, bipolar disorder not otherwise specified, or any other primary psychiatric disorder other than bipolar I disorder mania
- Thyroid pathology
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: Abilify, BMS-3370395-, 10-, or 15-mg oral tablets in titrated doses for 12 weeks | Drug | Aripiprazole + valproate or lithium |
| PlaceboTablets, Oral, 0 mg, once daily, 12 weeks | Drug | Placebo + valproate or lithium |
| LithiumParticipant's ongoing dose | Drug | Aripiprazole + valproate or lithium, Placebo + valproate or lithium |
| ValproateParticipant's ongoing dose | Drug | Aripiprazole + valproate or lithium, Placebo + valproate or lithium |
Primary outcome
Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set)
Time frame: Baseline to Week 12
The YMRS is a clinician-administered scale, consisting of 11 multiple choice items, and used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-though disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward.
11 secondary outcomes
Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set)
Time frame: Baseline to Weeks 3, 6, 9, and 12
Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Depression) Scale (LOCF Data Set)
Time frame: Baseline to Weeks 3, 6, 9, and 12
Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Overall) Scale at Week 12 (LOCF Data Set)
Time frame: Baseline to Week 12
Change From Baseline in Total and Subscale Scores on the Functional Assessment Short Test (FAST)(LOCF Data Set)
Time frame: Baseline to Weeks 3, 6, 9, and 12
Percentage of Participants Showing A Response From Baseline on the Young Mania Rating Scale (YMRS)(OC Data Set)
Time frame: Baseline to Weeks 3, 6, 9, and 12
Percentage of Participants Showing Remission in the Young Mania Rating Scale (YMRS) Score From Baseline (LOCF Data Set)
Time frame: Baseline to Weeks 3,6, 9, and 12
Change From Baseline in Total Score on the Longitudinal Interval Follow-up Evaluation-Rating Impaired Functioning Tool (LIFE-RIFT)(OC Data Set and Week 12 LOCF Data Set)
Time frame: Baseline to Weeks 6 and 12
Participant Scores on Patient Global Impression Improvement (PGI-I) Scale (OC Data Set)
Time frame: Baseline to Weeks 3, 6, 9, and 12
Change From Baseline in Participant Weight (OC Data Set and Week 12 LOCF Data Set)
Time frame: Baseline to Weeks 3, 6, 9, and 12
Percentage of Participants With Relevant Weight Gain or Weight Loss From Baseline at Week 12 (LOCF Data Set)
Time frame: Baseline to Weeks 3, 6, 9, and12
Change From Baseline to Week 12 in Body Mass Index (BMI) (LOCF Data Set)
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2013.
- 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
73 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aripiprazole, Lithium and Valproate in people with Bipolar Disorder Mania, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 73 sites in 13 countries.
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 10 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 2 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in France, Italy, Russia, Hungary, Poland and 8 more countries. 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 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 4 Feb 2013). 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?
Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set) (time frame: Baseline to Week 12). 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 2 Dec 2013.