Bipolar 1 DisorderPhase 3NCT01396291
Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384)
A Phase 3 study testing asenapine in people with Bipolar 1 Disorder, run by Forest Laboratories at 80 sites in 10 countries.
Trial summary
This study is being done to evaluate the efficacy and safety of asenapine as compared to placebo in preventing the recurrence of mood episodes after stabilization of an acute/manic mixed episode in participants with Bipolar 1 Disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar 1 Disorder
- What is being tested?
- asenapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 561 participants
- Where
- 80 sitesin 10 countries
- Study dates
- Dec 2011to Jun 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception.
- Each participant must be willing and able to provide written informed consent.
- Each participant must have an identified external contact person or an identified responsible person.
- Current diagnosis of Bipolar 1 Disorder, and a current manic (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision [DSM-IV-TR^TM] code 296.4x) or mixed (DSM-IV code 296.6x) episode as determined by a structured clinical interview (Mini International Neuropsychiatric Interview [MINI]) at Screening.
- Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode.
Who cannot join
- Uncontrolled, unstable clinically significant medical condition.
- Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram findings at Screening.
- Current primary Axis I disorder other than bipolar 1 disorder.
- Meets the current DSM-IV-TR^TM criteria for substance abuse or dependence (excluding nicotine).
- Imminent risk of self-harm or harm to others.
Trial locations and contacts
80 sites in 10 countries.
80 sites in 10 countries
United States30 sites
Forest Investigative Site 3002
Albuquerque, New Mexico, 87108
Forest Investigative Site 3017
Anaheim, California, 92805
Forest Investigative Site 3039
Atlanta, Georgia, 30331
Forest Investigative Site 3037
Avon Lake, Ohio, 44012
Forest Investigative Site 3032
Chicago, Illinois, 60640
Forest Investigative Site 3019
Chino, California, 91710
Forest Investigative Site 3041
Cincinnati, Ohio, 45219
Forest Investigative Site 3042
Colorado Springs, Colorado, 80910
Forest Investigative Site 3024
Elmsford, New York, 10523
Forest Investigative Site 3001
Escondido, California, 92025
Forest Investigative Site 3014
Gladstone, Missouri, 64118
Forest Investigative Site 3009
Houston, Texas, 77030
Forest Investigative Site 3020
Houston, Texas, 77090
Forest Investigative Site 3036
Irving, Texas, 75062
Forest Investigative Site 3012
Jacksonville, Florida, 32256
Forest Investigative Site 3040
Kissimmee, Florida, 34741
Forest Investigative Site 3031
Leesburg, Florida, 34748
Forest Investigative Site 3033
Memphis, Tennessee, 38119
Forest Investigative Site 3015
Miami, Florida, 33126
Forest Investigative Site 3004
National City, California, 91950
Forest Investigative Site 3006
Oakland, California, 94612
Forest Investigative Site 3023
Oklahoma City, Oklahoma, 73112
Forest Investigative Site 3035
Oklahoma City, Oklahoma, 73116
Forest Investigative Site 3003
Orange, California, 92868
Forest Investigative Site 3027
Plano, Texas, 75093
Forest Investigative Site 3029
Schaumburg, Illinois, 60194
Forest Investigative Site 3010
Tampa, Florida, 33613
Forest Investigative Site 3007
Torrance, California, 90502
Forest Investigative Site 3000
Wichita Falls, Texas, 76309
Forest Investigative Site 3021
Witchita, Kansas, 67207
Bulgaria7 sites
Forest Investigative Site 3102
Burgas, 8000
Forest Investigative Site 3105
Pleven, Pleven, 5800
Forest Investigative Site 3104
Sofia, Sofia-Grad, 1000
Forest Investigative Site 3100
Sofia, Sofia-Grad, 1202
Forest Investigative Site 3106
Sofia, Sofia-Grad, 1632
Forest Investigative Site 3101
Varna, Varna, 9010
Forest Investigative Site 3103
Varna, 9010
Romania7 sites
Forest Investigative Site 3127
Arad, 310022
Forest Investigative Site 3128
Bucharest, Bucharest, 011426
Forest Investigative Site 3129
Bucharest, Bucharest, 041914
Forest Investigative Site 3130
Bucharest, Bucharest, 041914
Forest Investigative Site 3125
Iași, Iaşi, 700282
Forest Investigative Site 3131
Targoviste, Dâmbovița County, 130086
Forest Investigative Site 3126
Targu Mureş, Mureș County, 540139
Serbia7 sites
Forest Investigative Site 3177
Belgrade, Belgrade, 11000
Forest Investigative Site 3176
Belgrade, Beograd, 11000
Forest Investigative Site 3179
Belgrade, Beograd, 11000
Forest Investigative Site 3182
Belgrade, Beograd, 11000
Forest Investigative Site 3178
Kragujevac, Kragujevac, 34000
Forest Investigative Site 3180
Kragujevac, Kragujevac, 34000
Forest Investigative Site 3182
Novi Kneževac, Vojvodina, 23330
Ukraine7 sites
Forest Investigative Site 3230
Chernihiv, Chernihiv Oblast, 14000
Forest Investigative Site 3228
Kharkiv, Kharkiv Oblast, 61068
Forest Investigative Site 3233
Kherson, 73488
Forest Investigative Site 3226
Kyiv, Kyiv Oblast, 01030
Forest Investigative Site 3229
Kyiv, Kyiv Oblast, 254655
Forest Investigative Site 3227
Luhansk, Luhansk Oblast, 91045
Forest Investigative Site 3232
Lviv, 79010
India6 sites
Forest Investigative Site 3306
Ahmedabad, Gujarat, 380-006
Forest Investigative Site 3305
Ahmedabad, Gujaratc, 380013
Forest Investigative Site 3303
Hyderabad, 500034
Forest Investigative Site 3302
Kanpur, Uttar Pradesh, 208005
Forest Investigative Site 3308
Nashik, Andhra Pradesh, 422101
Forest Investigative Site 3307
Nashik, Madhya Pradesh, 422101
Russia5 sites
Forest Investigative Site 3205
Kazan', Kazan, 420012
Forest Investigative Site 3202
Moscow, Moscow, 107076
Forest Investigative Site 3200
Moscow, Moscow, 115419
Forest Investigative Site 3201
Saint Petersburg, Sankt-Peterburg, 190005
Forest Investigative Site 3204
Smolensk, Smolensk Oblast, 214019
Croatia4 sites
Forest Investigative Site 3156
Rijeka, Rijeka, 51000
Forest Investigative Site 3153
Zagreb, City of Zagreb, 10000
Forest Investigative Site 3154
Zagreb, City of Zagreb, 10000
Forest Investigative Site 3152
Zagreb, City of Zagreb, 10090
Philippines4 sites
Forest Investigative Site 3353
Cebu, Cebu, 6000
Forest Investigative Site 3352
Iloilo City, Iloilo, 5000
Forest Investigative Site 3356
Mandaluyong, Mandaluyong, 1553
Forest Investigative Site 3351
Manila, National Capital Region, 1000
Turkey (Türkiye)3 sites
Forest Investigative Site 3255
Ankara, Ankara, 06100
Forest Investigative Site 3257
Diyarbakır, Diyarbakır, 21280
Forest Investigative Site 3252
Korucuk, Adapazari, 54290
About this study
Official title: A Double-Blind, Placebo-Controlled Trial of Asenapine in the Prevention of Recurrence of a Mood Episode After Stabilization of an Acute Manic/Mixed Episode in Subjects With Bipolar 1 Disorder (Phase 3B, Protocol P06384)
This study is being done to evaluate the efficacy and safety of asenapine as compared to placebo in preventing the recurrence of mood episodes after stabilization of an acute/manic mixed episode in participants with Bipolar 1 Disorder. After a Screening Period, each participant will receive open-label asenapine and matching placebo for 12 to 16 weeks. Participants who meet stabilization criteria may then be randomized into one of the two study arms (asenapine or matching placebo) to receive double-blind treatment for up to an additional 26-weeks.
- Conditions
- Bipolar 1 Disorder
- Being tested
- asenapine, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asenapineDrug
Also called SCH 900274, Saphris®, Sycrest®, Org 5222
asenapine, sublingual tablets, 5 to 10 mg twice per day (BID)
placeboDrug
asenapine-matched placebo, sublingual tablets, BID
| Study group | Role | What they receive |
|---|---|---|
| Asenapine | Experimental | All study participants will first receive open-label asenapine and placebo for 12 to 16 weeks before being randomized. After randomization, participants will receive asenapine or placebo (this is the double-blind period) for up to 26 weeks. Receives: Drug: asenapine |
| Placebo | Placebo comparator | All study participants will first receive open-label asenapine and placebo for 12 to 16 weeks before being randomized. After randomization, participants will receive asenapine or placebo (this is the double-blind period) for up to 26 weeks. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time (in days) to recurrence of any mood event during the double-blind treatment period
Measured: From Week 12 or 16 to Week 38 or 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar 1 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 561 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396291
- Sponsor's protocol ID
- P06384
- Other IDs
- 2010-018671-20
- Status last verified
- Dec 2015
- First submitted
- 14 Jul 2011
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Szegedi A, Durgam S, Mackle M, Yu SY, Wu X, Mathews M, Landbloom RP. Randomized, Double-Blind, Placebo-Controlled Trial of Asenapine Maintenance Therapy in Adults With an Acute Manic or Mixed Episode Associated With Bipolar I Disorder. Am J Psychiatry. 2018 Jan 1;175(1):71-79. doi: 10.1176/appi.ajp.2017.16040419. Epub 2017 Sep 26.
PubMed 28946761
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Trial of Asenapine in the Prevention of Recurrence of a Mood Episode After Stabilization of an Acute Manic/Mixed Episode in Subjects With Bipolar 1 Disorder (Phase 3B, Protocol P06384)
- ClinicalTrials.gov ID
- NCT01396291
- Acronym / sponsor ID
- P06384
- Conditions
- Bipolar 1 Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 561 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Jul 2011 (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.
This study is being done to evaluate the efficacy and safety of asenapine as compared to placebo in preventing the recurrence of mood episodes after stabilization of an acute/manic mixed episode in participants with Bipolar 1 Disorder. After a Screening Period, each participant will receive open-label asenapine and matching placebo for 12 to 16 weeks. Participants who meet stabilization criteria may then be randomized into one of the two study arms (asenapine or matching placebo) to receive double-blind treatment for up to an additional 26-weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asenapine | Experimental | Drug: asenapineAll study participants will first receive open-label asenapine and placebo for 12 to 16 weeks before being randomized. After randomization, participants will receive asenapine or placebo (this is the double-blind period) for up to 26 weeks. |
| Placebo | Placebo comparator | Drug: placeboAll study participants will first receive open-label asenapine and placebo for 12 to 16 weeks before being randomized. After randomization, participants will receive asenapine or placebo (this is the double-blind period) for up to 26 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception.
- Each participant must be willing and able to provide written informed consent.
- Each participant must have an identified external contact person or an identified responsible person.
- Current diagnosis of Bipolar 1 Disorder, and a current manic (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision [DSM-IV-TR^TM] code 296.4x) or mixed (DSM-IV code 296.6x) episode as determined by a structured clinical interview (Mini International Neuropsychiatric Interview [MINI]) at Screening.
- Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode.
Key exclusion criteria (5 listed)
- Uncontrolled, unstable clinically significant medical condition.
- Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram findings at Screening.
- Current primary Axis I disorder other than bipolar 1 disorder.
- Meets the current DSM-IV-TR^TM criteria for substance abuse or dependence (excluding nicotine).
- Imminent risk of self-harm or harm to others.
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 |
|---|---|---|
| asenapineAlso: SCH 900274, Saphris®, Sycrest®, Org 5222asenapine, sublingual tablets, 5 to 10 mg twice per day (BID) | Drug | Asenapine |
| placeboasenapine-matched placebo, sublingual tablets, BID | Drug | Placebo |
Primary outcome
The time (in days) to recurrence of any mood event during the double-blind treatment period
Time frame: From Week 12 or 16 to Week 38 or 42
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 4 Dec 2015.
- Derived from this study: PubMed 28946761Szegedi A, Durgam S, Mackle M, Yu SY, Wu X, Mathews M, Landbloom RP. Randomized, Double-Blind, Placebo-Controlled Trial of Asenapine Maintenance Therapy in Adults With an Acute Manic or Mixed Episode Associated With Bipolar I Disorder. Am J Psychiatry. 2018 Jan 1;175(1):71-79. doi: 10.1176/appi.ajp.2017.16040419. Epub 2017 Sep 26.
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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.
80 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing asenapine in people with Bipolar 1 Disorder, run by Forest Laboratories at 80 sites in 10 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 5 inclusion and 5 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 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in United States, Bulgaria, Romania, Serbia, Ukraine and 5 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?
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?
The time (in days) to recurrence of any mood event during the double-blind treatment period (time frame: From Week 12 or 16 to Week 38 or 42). 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 NCT01396291, which also lists 1 linked publication.
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 4 Dec 2015.