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12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00145470
Recruitment Status : Completed
First Posted : September 5, 2005
Results First Posted : September 16, 2019
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

Brief Summary:
This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Asenapine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Placebo-Controlled, Double-Blinded Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Continuing Lithium or Valproic Acid/Divalproex Sodium for the Treatment of an Acute Manic or Mixed Episode
Actual Study Start Date : June 2, 2005
Actual Primary Completion Date : February 28, 2007
Actual Study Completion Date : March 22, 2007


Arm Intervention/treatment
Experimental: Asenapine
Participants received asenapine as a fast-dissolving sublingual (SL) tablet, given twice daily (BID). On Day 1, participants received asenapine 5 mg, BID. On Days 2 to 84, asenapine was dosed flexibly: BID at either 5 or 10 mg. Asenapine doses were up- or down-titrated based on efficacy, safety, and tolerability.
Drug: Asenapine
Asenapine fast dissolving SL tablets 5 and 10 mg; starting dose 5 mg BID on Day 1; 5-10 mg BID after Day 1.
Other Name: Org 5222

Placebo Comparator: Placebo
Participants received placebo on Days 1-84 as a fast-dissolving SL tablet, BID.
Drug: Placebo
Placebo fast dissolving SL tablets, BID




Primary Outcome Measures :
  1. Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 21 [ Time Frame: Baseline and Day 21 ]
    The least squares mean change from baseline in Y-MRS score at day 21 was assessed. The Y-MRS is a clinician-rated instrument used for assessing the symptoms of mania, composed of 11 items. For the 11 items, scores range from 0 (symptoms absent) to, depending on the item, either 4 (7 items) or 8 (4 items). Scores for individual items add to a total score (range: 0-60), with higher scores indicating greater symptom severity. Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a last observation carried forward (LOCF) analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.


Secondary Outcome Measures :
  1. Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to Day 114 ]
    The number of participants experiencing an AE was assessed. An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the use of the investigational product, whether or not considered related to the investigational product.

  2. Number of Participants Discontinuing Study Treatment Due to an AE [ Time Frame: Up to Day 84 ]
    The number of participants discontinuing study treatment due to an AE was assessed. An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the use of the investigational product, whether or not considered related to the investigational product.

  3. Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 42 [ Time Frame: Baseline and Day 42 ]
    The least squares mean change from baseline in Y-MRS score at day 42 was assessed. The Y-MRS is a clinician-rated instrument used for assessing the symptoms of mania, composed of 11 items. For the 11 items, scores range from 0 (symptoms absent) to, depending on the item, either 4 (7 items) or 8 (4 items). Scores for individual items add to a total score (range: 0-60), with higher scores indicating greater symptom severity. Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.

  4. Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 84 [ Time Frame: Baseline and Day 84 ]
    The least squares mean change from baseline in Y-MRS score at day 84 was assessed. The Y-MRS is a clinician-rated instrument used for assessing the symptoms of mania, composed of 11 items. For the 11 items, scores range from 0 (symptoms absent) to, depending on the item, either 4 (7 items) or 8 (4 items). Scores for individual items add to a total score (range: 0-60), with higher scores indicating greater symptom severity. Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.

  5. Number of Participants Achieving Young-Mania Rating Scale (Y-MRS) Responder Status [ Time Frame: Up to Day 84 ]
    The Y-MRS is a clinician-rated instrument used for assessing the symptoms of mania, composed of 11 items. For the 11 items, scores range from 0 (symptoms absent) to, depending on the item, either 4 (7 items) or 8 (4 items). Scores for individual items add to a total score (range: 0-60), with higher scores indicating greater symptom severity. At pre-specified time points, the number of participants achieving Y-MRS responder status was assessed, defined as the number of participants with a 50% decrease from baseline in Y-MRS total score. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.

  6. Number of Participants Achieving Young-Mania Rating Scale (Y-MRS) Remitter Status [ Time Frame: Up to Day 84 ]
    The Y-MRS is a clinician-rated instrument used for assessing the symptoms of mania, composed of 11 items. For the 11 items, scores range from 0 (symptoms absent) to, depending on the item, either 4 (7 items) or 8 (4 items). Scores for individual items add to a total score (range: 0-60), with higher scores indicating greater symptom severity. At pre-specified time points, the number of participants achieving Y-MRS remitter status was assessed, defined as the number of participants with a Y-MRS total score of 12 or lower. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.

  7. Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Mania Score at Day 21 [ Time Frame: Baseline and Day 21 ]
    The least squares mean change from baseline in CGI-BP severity of mania score at day 21 was assessed. The CGI-BP severity of mania scale is a clinician-rated scale for assessing the severity of manic symptoms of bipolar disorder, with scores ranging from 1 (normal) to 7 (very severely ill). Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.

  8. Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Mania Score at Day 84 [ Time Frame: Baseline and Day 84 ]
    The least squares mean change from baseline in CGI-BP severity of mania score at day 84 was assessed. The CGI-BP severity of mania scale is a clinician-rated scale for assessing the severity of manic symptoms of bipolar disorder, with scores ranging from 1 (normal) to 7 (very severely ill). Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.

  9. Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Depression Score at Day 21 [ Time Frame: Baseline and Day 21 ]
    The least squares mean change from baseline in CGI-BP severity of depression score at day 21 was assessed. The CGI-BP severity of depression scale is a clinician-rated scale for assessing the severity of depressive symptoms of bipolar disorder, with scores ranging from 1 (normal) to 7 (very severely ill). Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.

  10. Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Depression Score at Day 84 [ Time Frame: Baseline and Day 84 ]
    The least squares mean change from baseline in CGI-BP severity of depression score at day 84 was assessed. The CGI-BP severity of depression scale is a clinician-rated scale for assessing the severity of depressive symptoms of bipolar disorder, with scores ranging from 1 (normal) to 7 (very severely ill). Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.

  11. Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Overall Bipolar Illness Score at Day 21 [ Time Frame: Baseline and Day 21 ]
    The least squares mean change from baseline in CGI-BP severity of severity of overall bipolar illness score at day 21 was assessed. The CGI-BP severity of overall bipolar illness scale is a clinician-rated scale for assessing the severity of overall symptoms of bipolar disorder, with scores ranging from 1 (normal) to 7 (very severely ill). Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.

  12. Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Overall Bipolar Illness Score at Day 84 [ Time Frame: Baseline and Day 84 ]
    The least squares mean change from baseline in CGI-BP severity of severity of overall bipolar illness score at day 84 was assessed. The CGI-BP severity of overall bipolar illness scale is a clinician-rated scale for assessing the severity of overall symptoms of bipolar disorder, with scores ranging from 1 (normal) to 7 (very severely ill). Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.

  13. Least Squares Mean Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Score at Day 21 [ Time Frame: Baseline and Day 21 ]
    The least squares mean change from baseline in MADRS score at day 21 was assessed. The MARDS is a clinician-rated scale for assessing the severity of symptoms of depression, composed of 10 items. For the 10 items, scores range from 0 (symptoms absent) to 6 (severe). Scores for individual items add to a total score (range: 0-60), with higher scores indicating greater severity of depression. Further, decreases in depression severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.

  14. Least Squares Mean Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Score at Day 84 [ Time Frame: Baseline and Day 84 ]
    The least squares mean change from baseline in MADRS score at day 84 was assessed. The MARDS is a clinician-rated scale for assessing the severity of symptoms of depression, composed of 10 items. For the 10 items, scores range from 0 (symptoms absent) to 6 (severe). Scores for individual items add to a total score (range: 0-60), with higher scores indicating greater severity of depression. Further, decreases in depression severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.

  15. Least Squares Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Day 21 [ Time Frame: Baseline and Day 21 ]
    The least squares mean change from baseline in PANSS score at day 21 was assessed. The PANSS assesses the severity of schizophrenia symptoms through a clinician-rated inventory of 30 items organized in 3 subscales: 1) positive subscale (7 items); 2) negative subscale (7 items); and 3) general psychopathology subscale (16 items). For each item, symptoms are scored from 1 (absent) to 7 (extreme) and add to a total PANSS score (range: 30-210). Higher scores reflect more severe symptoms of schizophrenia. Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.

  16. Least Squares Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Day 84 [ Time Frame: Baseline and Day 84 ]
    The least squares mean change from baseline in PANSS score at day 84 was assessed. The PANSS assesses the severity of schizophrenia symptoms through a clinician-rated inventory of 30 items organized in 3 subscales: 1) positive subscale (7 items); 2) negative subscale (7 items); and 3) general psychopathology subscale (16 items). For each item, symptoms are scored from 1 (absent) to 7 (extreme) and add to a total PANSS score (range: 30-210). Higher scores reflect more severe symptoms of schizophrenia. Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.

  17. Least Squares Mean Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Day 21 [ Time Frame: Baseline and Day 21 ]
    The least squares mean change from baseline in HAM-A score at day 21 was assessed. The HAM-A is a clinician-rated instrument for assessing anxiety symptoms, composed of 14 items. For the 14 items, scores range from 0 (not present) to 4 (severe). Scores for individual items add to a total score (range: 0-56), with higher scores indicating greater severity of anxiety. Further, decreases in anxiety severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.

  18. Least Squares Mean Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Day 84 [ Time Frame: Baseline and Day 84 ]
    The least squares mean change from baseline in HAM-A score at day 84 was assessed. The HAM-A is a clinician-rated instrument for assessing anxiety symptoms, composed of 14 items. For the 14 items, scores range from 0 (not present) to 4 (severe). Scores for individual items add to a total score (range: 0-56), with higher scores indicating greater severity of anxiety. Further, decreases in anxiety severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.

  19. Least Squares Mean Change From Baseline in InterSePT Scale for Suicidal Thinking - Modified Version (ISST-Modified) Score at Day 21 [ Time Frame: Baseline and Day 21 ]
    The least squares mean change from baseline in ISST-Modified score at day 21 was assessed. The ISST-Modified is a clinician-rated scale for rating suicidality, composed of 12 items (score range: 0-2). Scores for the 12 items add to a total ISST-Modified score (range: 0-24), with higher scores indicating increased severity of suicidal thinking. Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.

  20. Least Squares Mean Change From Baseline in InterSePT Scale for Suicidal Thinking - Modified Version (ISST-Modified) Score at Day 84 [ Time Frame: Baseline and Day 84 ]
    The least squares mean change from baseline in ISST-Modified score at day 84 was assessed. The ISST-Modified is a clinician-rated scale for rating suicidality, composed of 12 items (score range: 0-2). Scores for the 12 items add to a total ISST-Modified score (range: 0-24), with higher scores indicating increased severity of suicidal thinking. Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.

  21. Mean Change From Baseline (CFB) at Day 21 in Neurocognitive Function as Determined by Central Nervous System Vital Signs (CNS-VS) Test Battery [ Time Frame: Baseline and Day 21 ]

    Nine neurocognitive tests with higher scores indicating better performance:

    1. Verbal Memory test: recognize/remember/retrieve words (range 0-60)
    2. Visual Memory test: recognize/remember/retrieve geometric figures (range 0-60)
    3. Speed of Processing: recognize/process information. No min./max. score. Normative average (NA); correct answers: 65.1, avg. errors: 1.37
    4. Social Acuity/Perception of Emotions test: perceive/respond to emotional cues. Min. score: -64/Max. score: 16
    5. Reasoning: reason/respond to non-verbal, visual-abstract stimuli; scores range: -15 to 15
    6. Executive Function: recognize rules/categories/decision making. No min./max. score. NA correct answers: 55.01/avg. errors: 5.28
    7. Working Memory/Continuous Performance Task (CPT): perceive/attend to symbols. Min. score: -45/Max. score: 15
    8. Sustained Attention: direct/focus on specific stimuli: Max. score (raw score); 45; Min. score: -170
    9. Composite Memory: working+verbal+visual memory, Range 0-135.

  22. Mean Change From Baseline (CFB) at Day 84 in Neurocognitive Function as Determined by Central Nervous System Vital Signs (CNS-VS) Test Battery [ Time Frame: Baseline and Day 84 ]

    Nine neurocognitive tests with higher scores indicating better performance:

    1. Verbal Memory test: recognize/remember/retrieve words (range 0-60)
    2. Visual Memory test: recognize/remember/retrieve geometric figures (range 0-60)
    3. Speed of Processing: recognize/process information. No min./max. score. Normative average (NA); correct answers: 65.1, avg. errors: 1.37
    4. Social Acuity/Perception of Emotions test: perceive/respond to emotional cues. Min. score: -64/Max. score: 16
    5. Reasoning: reason/respond to non-verbal, visual-abstract stimuli; scores range: -15 to 15
    6. Executive Function: recognize rules/categories/decision making. No min./max. score. NA correct answers: 55.01/avg. errors: 5.28
    7. Working Memory/Continuous Performance Task (CPT): perceive/attend to symbols. Min. score: -45/Max. score: 15
    8. Sustained Attention: direct/focus on specific stimuli: Max. score (raw score); 45; Min. score: -170
    9. Composite Memory: working+verbal+visual memory, Range 0-135.

  23. Percentage of Participants Determined to be Ready to Discharge at Day 84 (Kaplan-Meier Estimation) [ Time Frame: Day 84 ]

    The percentage of participants determined to be ready to discharge at day 84 was estimated (Kaplan-Meier), using the readiness to discharge questionnaire (RDQ). The RDQ is clinician-rated scale to assess readiness for discharge, composed of 7 items. Of the 7 items, only the first 5 items were utilized:

    1. Not actively suicidal/homicidal;
    2. Adequate control over aggression and impulsivity;
    3. Able to carry out basic activities of daily life;
    4. Able to take medicine independently; and
    5. Delusions and hallucinations do not significantly interfere with functioning.

    For the 5 items, the clinician provided a response (Strongly Disagree; Disagree; Agree; or Strongly Agree) at each pre-specified visit. The first visit at which the responses to the first 5 items on the RDQ are "Strongly Agree" or "Agree," was defined as the point a participant was ready to discharge.


  24. Least Squares Mean Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), General Activities Subscale Score at Day 21 [ Time Frame: Baseline and Day 21 ]
    The least squares mean change from baseline in Q-LES-Q score at day 21 was assessed. The Q-LES-Q is a participant-completed questionnaire to assess general satisfaction with activities such as physical health, mood, work, household tasks, social and family relationships, leisure activities, and overall satisfaction, composed of 16 items. For each of the 16 items, scores range from 0 (very poor) to 5 (very good), with scores for all items adding to a total score (range: 0-80); higher scores indicate better quality of life. Further, decreases in quality of life are reflected by a negative change from baseline.

  25. Least Squares Mean Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), General Activities Subscale Score at Day 84 [ Time Frame: Baseline and Day 84 ]
    The least squares mean change from baseline in Q-LES-Q score at day 84 was assessed. The Q-LES-Q is a participant-completed questionnaire to assess general satisfaction with activities such as physical health, mood, work, household tasks, social and family relationships, leisure activities, and overall satisfaction, composed of 16 items. For each of the 16 items, scores range from 0 (very poor) to 5 (very good), with scores for all items adding to a total score (range: 0-80); higher scores indicate better quality of life. Further, decreases in quality of life are reflected by a negative change from baseline.

  26. Least Squares Mean Change From Baseline at Day 21 in Quality of Life as Determined by Short Form-36 Version 2 (SF-36v2) [ Time Frame: Baseline and Day 21 ]
    Least squares mean change from baseline at day 21 in quality of life was assessed, as determined by SF-36v2. The SF-36v2 is a self-administered questionnaire, measuring 8 domains: Physical Functioning (PF); Role-Physical (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role-Emotional (RE); and Mental Health (MH). These 8 concepts are further organized into a Physical Component Summary (PCS; composite of PF, RP, BP, and GH) and a Mental Component Summary (MCS; composite of VT, SF, RE, and MH). The SF-36v2 domains and composite summaries were scored using a norm-based scoring approach, yielding a mean of 50 and standard deviation of 10 based on the norms from the 1998 SF-36 United States general population norms. For the PCS and MCS, scores range from 0 to 100, with higher scores indicating better quality of life. Further, decreases in quality of life (by PCS and MCS) are reflected by a negative change from baseline.

  27. Least Squares Mean Change From Baseline at Day 84 in Quality of Life as Determined by Short Form-36 Version 2 (SF-36v2) [ Time Frame: Baseline and Day 21 ]
    Least squares mean change from baseline at day 84 in quality of life was assessed, as determined by SF-36v2. The SF-36v2 is a self-administered questionnaire, measuring 8 domains: Physical Functioning (PF); Role-Physical (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role-Emotional (RE); and Mental Health (MH). These 8 concepts are further organized into a Physical Component Summary (PCS; composite of PF, RP, BP, and GH) and a Mental Component Summary (MCS; composite of VT, SF, RE, and MH). The SF-36v2 domains and composite summaries were scored using a norm-based scoring approach, yielding a mean of 50 and standard deviation of 10 based on the norms from the 1998 SF-36 United States general population norms. For the PCS and MCS, scores range from 0 to 100, with higher scores indicating better quality of life. Further, decreases in quality of life (by PCS and MCS) are reflected by a negative change from baseline.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have bipolar I disorder, current episode manic or mixed
  • Treated with lithium or valproic acid

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145470


Sponsors and Collaborators
Organon and Co
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
Publications of Results:
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Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00145470    
Other Study ID Numbers: P05844
A7501008 ( Other Identifier: Organon )
2004-003927-11 ( EudraCT Number )
MK-8274-017 ( Other Identifier: Merck Protocol Number )
P05844 ( Other Identifier: Schering-Plough )
First Posted: September 5, 2005    Key Record Dates
Results First Posted: September 16, 2019
Last Update Posted: February 8, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Asenapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs