Bipolar 1 DisorderPhase 3NCT00764478
Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691)
A Phase 3 study testing Asenapine in people with Bipolar 1 Disorder, run by Organon and Co.
Trial summary
This trial will study the efficacy and safety of a fixed dose of asenapine in participants diagnosed with Bipolar 1 Disorder. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 5 mg or 10 mg twice daily [BID]) or placebo (BID) for 3 weeks. 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
- 367 participants
- Where
- No sites listed yet
- Study dates
- 6 Apr 2012to 28 May 2014
- 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
- Each participant must be at least 18 years of age
- 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 have a current diagnosis of Bipolar I Disorder, current episode manic or mixed
- Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode
- Each participant must have discontinued the use of all prohibited psychotropic medications
Who cannot join
- A participant must not have a primary Axis I disorder other than Bipolar 1 Disorder (i.e., an Axis 1 disorder other than Bipolar 1 Disorder that is primarily responsible for current symptoms and functional impairment)
- A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR™) criteria for substance abuse or dependence (excluding nicotine)
- A participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (CSSRS).
About this study
Official title: A Phase 3b, Multicenter, Double-Blind, Fixed-Dose, Parallel-Group, Three Week Placebo Controlled Trial Evaluating the Safety and Efficacy of Asenapine in Subjects With Bipolar 1 Disorder Experiencing an Acute Manic or Mixed Episode (Protocol P05691 [Formerly 041044])
This trial will study the efficacy and safety of a fixed dose of asenapine in participants diagnosed with Bipolar 1 Disorder. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 5 mg or 10 mg twice daily [BID]) or placebo (BID) for 3 weeks. Throughout the trial, observations will be made on each participant at various times to assess the safety and effectiveness of the study treatment. The primary hypothesis is that there is at least one dose of asenapine that is superior to placebo in the change from baseline in manic symptoms (as measured by Young Mania Rating Scale [YMRS]) at Day 21 of the trial.
- 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 tablet, 5 mg sublingually BID for 21 days
AsenapineDrug
Also called SCH 900274, Saphris®, Sycrest®, Org 5222
asenapine tablet, 10 mg sublingually BID for 21 days
PlaceboDrug
placebo sublingual tablet, administered BID for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Asenapine 5 mg BID | Experimental | Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days Receives: Drug: Asenapine |
| Asenapine 10 mg BID | Experimental | Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days Receives: Drug: Asenapine |
| Placebo BID | Placebo comparator | Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score at Day 21
Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a mixed model repeated measures (MMRM) model. An improvement in symptoms is represented by change from baseline values that are negative.
Measured: Baseline and Day 21
Secondary outcomes (22)
Change From Baseline in Clinical Global Impression - Bipolar Mania - Severity of Illness (CGI-BP-S) Overall Score at Day 21
The CGI-BP-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Measured: Baseline and Day 21
Percentage of Participants Who Are Y-MRS Responders at Day 21
Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by Last Observation Carried Forward (LOCF). Y-MRS responders are defined as having a >= 50% decrease from baseline in Y-MRS total score.
Measured: Day 21
Change From Baseline in Y-MRS Total Score at Day 2, Day 4, Day 7 and Day 14
Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Measured: Baseline and Day 2, Day 4, Day 7 and Day 14
Percentage of Participants Who Are Y-MRS Responders at Day 2, Day 4, Day 7, Day 14
Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF. Y-MRS responders are defined as having a >= 50% decrease from baseline in Y-MRS total score.
Measured: Day 2, Day 4, Day 7, Day 14
Percentage of Participants Who Are Y-MRS Remitters at Day 21
Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF. Y-MRS remitters are defined as having a Y-MRS total score of 12 or lower.
Measured: Day 21
Percentage of Participants Who Are Y-MRS Remitters at Day 2, Day 4, Day 7, Day 14, Day 21
Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a generalized linear mixed model (GLMM). Y-MRS remitters are defined as having a Y-MRS total score of 12 or lower.
Measured: Day 2, Day 4, Day 7, Day 14, Day 21
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
The MADRS measures depression and consists of 10 items, each rated on a scale from 0 to 6. The MADRS total score sums the scores from the 10 items, ranging from 0 to 60, with a higher numeric rating implying a greater degree of symptom severity. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.
Measured: Baseline and Day 7 and Day 21
Change From Baseline in CGI-BP-S Overall Score at Day 2, Day 4, Day 7, Day 14
The CGI-BP-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Measured: Baseline and Day 2, Day 4, Day 7, Day 14
Change From Baseline in CGI-BP-S Mania Score
The CGI-BP-S mania is a score that assesses the severity of the mania component of bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.
Measured: Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21
Change From Baseline in CGI-BP-S Depression Score
The CGI-BP-S depression is a score that assesses the severity of the depression component of bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.
Measured: Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Overall Bipolar Illness Score
The CGI-BP-I overall is a score on a 7-point scale for assessing the change from preceding phase of overall symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I overall score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.
Measured: Day 2, Day 4, Day 7, Day 14, and Day 21
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Mania Score
The CGI-BP-I mania is a score on a 7-point scale for assessing the change from preceding phase of mania symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I mania score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.
Measured: Day 2, Day 4, Day 7, Day 14, and Day 21
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Depression Score
The CGI-BP-I depression is a score on a 7-point scale for assessing the change from preceding phase of depression symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I depression score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.
Measured: Day 2, Day 4, Day 7, Day 14, and Day 21
Change From Baseline in Positive And Negative Syndrome Scale (PANSS) Total Score
PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score sums the scores from all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Measured: Baseline and Day 7, Day 14, Day 21
Change From Baseline in PANSS Negative Subscale Score
PANSS Negative subscale measures symptoms of schizophrenia and consists of responses to 7 items (N1-N7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Negative subscale sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Measured: Baseline and Day 7, Day 14, Day 21
Change From Baseline in PANSS Positive Subscale Score
PANSS Positive subscale measures symptoms of schizophrenia and consists of responses to 7 items (P1-P7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Positive subscale sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Measured: Baseline and Day 7, Day 14, Day 21
Change From Baseline in PANSS General Psychopathology Subscale Score
PANSS General Psychopathology subscale measures symptoms of schizophrenia and consists of responses to 16 items (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS General Psychopathology subscale sums the scores from all 16 items and ranges from 16 to 112, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Measured: Baseline and Day 7, Day 14, Day 21
Change From Baseline in PANSS Marder Factor Positive Symptom Score
PANSS Marder Factor Positive symptom score measures symptoms of schizophrenia and consists of responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Positive symptom score sums the scores from all 8 items and ranges from 8 to 56, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Measured: Baseline and Day 7, Day 14, Day 21
Change From Baseline in PANSS Marder Factor Negative Symptom Score
PANSS Marder Factor Negative symptom score measures symptoms of schizophrenia and consists of responses to 7 items (N1,N2,N3,N4,N6,G7,G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Negative symptom score sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Measured: Baseline and Day 7, Day 14, Day 21
Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score
PANSS Marder Factor Disorganized Thought symptom score measures symptoms of schizophrenia and consists of responses to 7 items (P2,N5,G5,G10,G11,G13,G15). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Disorganized Thought symptom score sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Measured: Baseline and Day 7, Day 14, Day 21
Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score
PANSS Marder Factor Hostility/Excitement symptom score measures symptoms of schizophrenia and consists of responses to 4 items (P4,P7,G8,G14). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Hostility/Excitement symptom score sums the score from all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Measured: Baseline and Day 7, Day 14, Day 21
Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score
PANSS Marder Factor Anxiety/Depression symptom score measures symptoms of schizophrenia and consists of responses to 4 items (G2,G3,G4,G6). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Anxiety/Depression symptom score sums the scores from all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Measured: Baseline and Day 7, Day14, Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study start6 Apr 2012
- Primary completion30 Apr 2014
- Study completion28 May 2014
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 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
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764478
- Sponsor's protocol ID
- P05691
- Other IDs
- 2010-018409-13, MK-8274-003
- Status last verified
- Feb 2022
- First submitted
- 30 Sep 2008
- Last updated
- 18 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Landbloom RL, Mackle M, Wu X, Kelly L, Snow-Adami L, McIntyre RS, Mathews M, Hundt C. Asenapine: Efficacy and safety of 5 and 10mg bid in a 3-week, randomized, double-blind, placebo-controlled trial in adults with a manic or mixed episode associated with bipolar I disorder. J Affect Disord. 2016 Jan 15;190:103-110. doi: 10.1016/j.jad.2015.06.059. Epub 2015 Sep 25.
PubMed 26496015
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Multicenter, Double-Blind, Fixed-Dose, Parallel-Group, Three Week Placebo Controlled Trial Evaluating the Safety and Efficacy of Asenapine in Subjects With Bipolar 1 Disorder Experiencing an Acute Manic or Mixed Episode (Protocol P05691 [Formerly 041044])
- ClinicalTrials.gov ID
- NCT00764478
- Acronym / sponsor ID
- P05691
- Conditions
- Bipolar 1 Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2012 (actual)
- Primary completion
- 30 Apr 2014 (actual)
- Study completion
- 28 May 2014 (actual)
- First posted
- 2 Oct 2008 (estimated)
- Results
- Posted 24 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will study the efficacy and safety of a fixed dose of asenapine in participants diagnosed with Bipolar 1 Disorder. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 5 mg or 10 mg twice daily [BID]) or placebo (BID) for 3 weeks. Throughout the trial, observations will be made on each participant at various times to assess the safety and effectiveness of the study treatment. The primary hypothesis is that there is at least one dose of asenapine that is superior to placebo in the change from baseline in manic symptoms (as measured by Young Mania Rating Scale [YMRS]) at Day 21 of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asenapine 5 mg BID | Experimental | Drug: AsenapineParticipants were administered one 5 mg asenapine tablet, sublingually BID for 21 days |
| Asenapine 10 mg BID | Experimental | Drug: AsenapineParticipants were administered one 10 mg asenapine tablet, sublingually BID for 21 days |
| Placebo BID | Placebo comparator | Drug: PlaceboParticipants were administered one asenapine-matched placebo tablet sublingually BID for 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Each participant must be at least 18 years of age
- 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 have a current diagnosis of Bipolar I Disorder, current episode manic or mixed
- Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode
- Each participant must have discontinued the use of all prohibited psychotropic medications
Key exclusion criteria (3 listed)
- A participant must not have a primary Axis I disorder other than Bipolar 1 Disorder (i.e., an Axis 1 disorder other than Bipolar 1 Disorder that is primarily responsible for current symptoms and functional impairment)
- A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR™) criteria for substance abuse or dependence (excluding nicotine)
- A participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (CSSRS).
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 tablet, 5 mg sublingually BID for 21 days | Drug | Asenapine 5 mg BID |
| AsenapineAlso: SCH 900274, Saphris®, Sycrest®, Org 5222asenapine tablet, 10 mg sublingually BID for 21 days | Drug | Asenapine 10 mg BID |
| Placeboplacebo sublingual tablet, administered BID for 21 days | Drug | Placebo BID |
Primary outcome
Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score at Day 21
Time frame: Baseline and Day 21
Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a mixed model repeated measures (MMRM) model. An improvement in symptoms is represented by change from baseline values that are negative.
22 secondary outcomes
Change From Baseline in Clinical Global Impression - Bipolar Mania - Severity of Illness (CGI-BP-S) Overall Score at Day 21
Time frame: Baseline and Day 21
Percentage of Participants Who Are Y-MRS Responders at Day 21
Time frame: Day 21
Change From Baseline in Y-MRS Total Score at Day 2, Day 4, Day 7 and Day 14
Time frame: Baseline and Day 2, Day 4, Day 7 and Day 14
Percentage of Participants Who Are Y-MRS Responders at Day 2, Day 4, Day 7, Day 14
Time frame: Day 2, Day 4, Day 7, Day 14
Percentage of Participants Who Are Y-MRS Remitters at Day 21
Time frame: Day 21
Percentage of Participants Who Are Y-MRS Remitters at Day 2, Day 4, Day 7, Day 14, Day 21
Time frame: Day 2, Day 4, Day 7, Day 14, Day 21
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline and Day 7 and Day 21
Change From Baseline in CGI-BP-S Overall Score at Day 2, Day 4, Day 7, Day 14
Time frame: Baseline and Day 2, Day 4, Day 7, Day 14
Change From Baseline in CGI-BP-S Mania Score
Time frame: Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21
Change From Baseline in CGI-BP-S Depression Score
Time frame: Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Overall Bipolar Illness Score
Time frame: Day 2, Day 4, Day 7, Day 14, and Day 21
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Mania Score
Time frame: Day 2, Day 4, Day 7, Day 14, and Day 21
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Depression Score
Time frame: Day 2, Day 4, Day 7, Day 14, and Day 21
Change From Baseline in Positive And Negative Syndrome Scale (PANSS) Total Score
Time frame: Baseline and Day 7, Day 14, Day 21
Change From Baseline in PANSS Negative Subscale Score
Time frame: Baseline and Day 7, Day 14, Day 21
Change From Baseline in PANSS Positive Subscale Score
Time frame: Baseline and Day 7, Day 14, Day 21
Change From Baseline in PANSS General Psychopathology Subscale Score
Time frame: Baseline and Day 7, Day 14, Day 21
Change From Baseline in PANSS Marder Factor Positive Symptom Score
Time frame: Baseline and Day 7, Day 14, Day 21
Change From Baseline in PANSS Marder Factor Negative Symptom Score
Time frame: Baseline and Day 7, Day 14, Day 21
Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score
Time frame: Baseline and Day 7, Day 14, Day 21
Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score
Time frame: Baseline and Day 7, Day 14, Day 21
Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score
Time frame: Baseline and Day 7, Day14, Day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26496015Landbloom RL, Mackle M, Wu X, Kelly L, Snow-Adami L, McIntyre RS, Mathews M, Hundt C. Asenapine: Efficacy and safety of 5 and 10mg bid in a 3-week, randomized, double-blind, placebo-controlled trial in adults with a manic or mixed episode associated with bipolar I disorder. J Affect Disord. 2016 Jan 15;190:103-110. doi: 10.1016/j.jad.2015.06.059. Epub 2015 Sep 25.
- Individual participant dataSharing planned: No
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Asenapine in people with Bipolar 1 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 5 inclusion and 3 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 18 Jun 2024. 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 24 Apr 2015). 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 Young Mania Rating Scale (Y-MRS) Total Score at Day 21 (time frame: Baseline and Day 21). 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 NCT00764478, 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 18 Jun 2024.