Bipolar DisorderPhase 3NCT00145509

40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)

A Phase 3 study testing Asenapine in people with Bipolar Disorder, run by Organon and Co.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Bipolar 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: 77 participants
Where: No sites listed yet
Study dates: Aug 2005to Dec 2007
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

Have bipolar I disorder (current episode manic or mixed), be treated with lithium or valproic acid, and have completed the a 12-week lead-in trial

Who cannot join

Have an unstable medical condition or clinically significant laboratory abnormality.
Have a primary diagnosis other than bipolar I disorder.

About this study

Official title: A Phase 3, Placebo-Controlled, Double-Blinded Continuation Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Completing a 12-week Lead-in Trial and Continuing Lithium or Valproic Acid/Divalproex Sodium for the Treatment of an Acute Manic or Mixed Episode

The primary objective of this trial was to characterize the long-term (up to 40 weeks) safety and tolerability of asenapine in bipolar I disorder subjects who had not completely responded to continuing treatment with lithium or valproic acid (VPA) for the treatment of an acute manic or mixed episodes upon enrollment into the 12-week lead-in trial, A7501008 (NCT00145470). The safety comparison was between the group receiving lithium or VPA and placebo against the group receiving lithium or VPA and asenapine, with the caveat that all subjects may have received benzodiazepine and/or antidepressant rescue medication as needed.

Conditions: Bipolar Disorder
Being tested: Asenapine, Placebo
Medical subject headings: Bipolar Disorder

What participants receive

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

AsenapineDrug
Also called Org 5222
Asenapine 5 or 10 mg twice daily (BID) sublingually for 40 weeks
PlaceboDrug
Fast-dissolving tablet; twice daily (BID) sublingually for 40 weeks

Study groups in NCT00145509
Study group	Role	What they receive
Asenapine	Active comparator	Asenapine Receives: Drug: Asenapine
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experienced an Adverse Event
Participants who experienced treatment-emergent adverse events, defined as adverse events reported on or after the first dose of study medication in the 12-week lead-in study through the last dose of study drug + 7 days (or + 30 days for serious adverse events).
Measured: up to 52 weeks
Number of Participants Who Discontinued Because of an Adverse Event
Participants who discontinued study medication due to adverse events.
Measured: 40 weeks
Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score
The Y-MRS is an 11-item, clinician-rated instrument used for assessing the symptoms of mania. Y-MRS total score range = 0-60; higher scores indicate greater severity of symptoms.
Measured: Baseline and 52 Weeks
Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score
The MADRS is a 10-item clinician-rated scale for assessing the severity of symptoms of depression. MADRS total score range = 0-60; higher scores indicate greater severity of symptoms.
Measured: Baseline and 52 Weeks

Timeline

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

Aug 2005Dec 2007

First posted5 Sep 2005 (estimated)
Study startAug 2005
Primary completionDec 2007
Study completionDec 2007

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.
Publications (1)Papers the sponsor has linked to this study.
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: Non-randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00145509
Sponsor's protocol ID: P05786
Other IDs: A7501009
Status last verified: Feb 2022
First submitted: 1 Sep 2005
Last updated: 8 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Szegedi A, Calabrese JR, Stet L, Mackle M, Zhao J, Panagides J; Apollo Study Group. Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension. J Clin Psychopharmacol. 2012 Feb;32(1):46-55. doi: 10.1097/JCP.0b013e31823f872f.
PubMed 22198448

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?

Official record

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Safety and Feasibility of DBS for Bipolar Depression
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All Bipolar Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Placebo-Controlled, Double-Blinded Continuation Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Completing a 12-week Lead-in Trial and Continuing Lithium or Valproic Acid/Divalproex Sodium for the Treatment of an Acute Manic or Mixed Episode
ClinicalTrials.gov ID: NCT00145509
Acronym / sponsor ID: P05786
Conditions: Bipolar Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Aug 2005
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 5 Sep 2005 (estimated)
Results: Posted 16 Apr 2010

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: Non-randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Asenapine	Active comparator	Drug: AsenapineAsenapine
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Have bipolar I disorder (current episode manic or mixed), be treated with lithium or valproic acid, and have completed the a 12-week lead-in trial

Key exclusion criteria (2 listed)

Have an unstable medical condition or clinically significant laboratory abnormality.
Have a primary diagnosis other than bipolar I disorder.

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: Org 5222Asenapine 5 or 10 mg twice daily (BID) sublingually for 40 weeks	Drug	Asenapine
PlaceboFast-dissolving tablet; twice daily (BID) sublingually for 40 weeks	Drug	Placebo

Primary outcome

Number of Participants Who Experienced an Adverse Event
Time frame: up to 52 weeks
Participants who experienced treatment-emergent adverse events, defined as adverse events reported on or after the first dose of study medication in the 12-week lead-in study through the last dose of study drug + 7 days (or + 30 days for serious adverse events).
Number of Participants Who Discontinued Because of an Adverse Event
Time frame: 40 weeks
Participants who discontinued study medication due to adverse events.
Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score
Time frame: Baseline and 52 Weeks
The Y-MRS is an 11-item, clinician-rated instrument used for assessing the symptoms of mania. Y-MRS total score range = 0-60; higher scores indicate greater severity of symptoms.
Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score
Time frame: Baseline and 52 Weeks
The MADRS is a 10-item clinician-rated scale for assessing the severity of symptoms of depression. MADRS total score range = 0-60; higher scores indicate greater severity of symptoms.

Results and safety

Results posted to the registry on 16 Apr 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Asenapine	41	19
Placebo	36	15

Primary outcome: Number of Participants Who Experienced an Adverse Event

Time frame: up to 52 weeks. Number. Unit: Participants

Measure	Asenapine n = 41	Placebo n = 36
Value	32	25

Primary outcome: Number of Participants Who Discontinued Because of an Adverse Event

Time frame: 40 weeks. Number. Unit: participants

Measure	Asenapine n = 41	Placebo n = 36
Value	10	3

Primary outcome: Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score

Time frame: Baseline and 52 Weeks. Mean (Standard Deviation). Unit: Score on a Scale

Measure	Asenapine n = 38	Placebo n = 33
Value	-17.2 (13.65)	-19.7 (11.81)

Population analysed: Intent-to-treat are subjects who took at least one dose of double-blind study medication in the extension study and had at least one Y-MRS and MADRS assessment during the extension study.

Primary outcome: Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score

Time frame: Baseline and 52 Weeks. Mean (Standard Deviation). Unit: Score on a scale

Measure	Asenapine n = 38	Placebo n = 33
Value	-3.3 (9.75)	-3.9 (7.71)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Asenapine	9 of 41 (22%)	25 of 41 (61%)	Not reported
Placebo	4 of 36 (11.1%)	18 of 36 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22198448Szegedi A, Calabrese JR, Stet L, Mackle M, Zhao J, Panagides J; Apollo Study Group. Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension. J Clin Psychopharmacol. 2012 Feb;32(1):46-55. doi: 10.1097/JCP.0b013e31823f872f.

Related trials for Bipolar Disorder

Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
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Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
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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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Asenapine in people with Bipolar Disorder, run by Organon and Co.

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 1 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: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

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 16 Apr 2010). 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?

Number of Participants Who Experienced an Adverse Event (time frame: up to 52 weeks). The study lists 4 primary outcomes in all. 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 NCT00145509, 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 8 Feb 2022.