- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00145470
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)
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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
Placebo Comparator: Placebo
Participants received placebo on Days 1-84 as a fast-dissolving SL tablet, BID.
|
Placebo fast dissolving SL tablets, BID
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and Day 21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to Day 114
|
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.
|
Up to Day 84
|
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.
|
Baseline and Day 42
|
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.
|
Baseline and Day 84
|
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.
|
Up to Day 84
|
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.
|
Up to Day 84
|
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.
|
Baseline and Day 21
|
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.
|
Baseline and Day 84
|
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.
|
Baseline and Day 21
|
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.
|
Baseline and Day 84
|
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.
|
Baseline and Day 21
|
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.
|
Baseline and Day 84
|
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.
|
Baseline and Day 21
|
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.
|
Baseline and Day 84
|
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.
|
Baseline and Day 21
|
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.
|
Baseline and Day 84
|
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.
|
Baseline and Day 21
|
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.
|
Baseline and Day 84
|
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.
|
Baseline and Day 21
|
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.
|
Baseline and Day 84
|
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:
|
Baseline and Day 21
|
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:
|
Baseline and Day 84
|
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:
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. |
Day 84
|
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.
|
Baseline and Day 21
|
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.
|
Baseline and Day 84
|
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.
|
Baseline and Day 21
|
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.
|
Baseline and Day 21
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P05844 (Other Identifier: Schering-Plough)
- A7501008 (Other Identifier: Organon)
- 2004-003927-11 (EudraCT Number)
- MK-8274-017 (Other Identifier: Merck Protocol Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bipolar Disorder
-
ProgenaBiomeRecruitingBipolar Disorder | Bipolar I Disorder | Bipolar II Disorder | Bipolar Type I Disorder | Bipolar Disorder Mild | Bipolar Disorder Moderate | Bipolar Disorder SevereUnited States
-
Region StockholmKarolinska InstitutetRecruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II Disorder | Bipolar Affective Disorder; Remission in | Bipolar Affective Disorder, Currently Depressed, ModerateSweden
-
University of PittsburghNational Alliance for Research on Schizophrenia and DepressionCompletedBipolar I Disorder | Bipolar II Disorder | Bipolar Disorder NOSUnited States
-
Hospital de Clinicas de Porto AlegreFederal University of Rio Grande do Sul; Hospital Moinhos de VentoActive, not recruitingBipolar Disorder | Bipolar Depression | Major Depressive Disorder | Bipolar I Disorder | Affective Disorder | Bipolar II DisorderBrazil
-
Rush University Medical CenterThe Ryan Licht Sang Bipolar FoundationCompletedBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar Disorder I | Bipolar Affective DisorderUnited States
-
Medical University of South CarolinaMilken InstituteCompletedBipolar Disorder | Bipolar I Disorder | Bipolar II DisorderUnited States
-
Mayo ClinicCompletedMajor Depressive Disorder, Bipolar I and Bipolar IIUnited States
-
Joshua RosenblatRecruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II DisorderCanada
-
Myriad Genetic Laboratories, Inc.University of MinnesotaCompletedMajor Depressive Disorder, Bipolar I and Bipolar IIUnited States
-
Centre for Addiction and Mental HealthUniversity Health Network, TorontoNot yet recruitingBipolar Disorder | Bipolar Depression | Treatment- Resistant Bipolar Disorder | Type 2 Bipolar DisorderCanada
Clinical Trials on Asenapine
-
Organon and CoCompleted
-
Lori Davis, MDMerck Sharp & Dohme LLC; Forest LaboratoriesCompletedAn Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress DisorderPosttraumatic Stress DisorderUnited States
-
Organon and CoCompleted
-
Duke UniversityMerck Sharp & Dohme LLCCompleted
-
Organon and CoCompleted
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompleted
-
Amneal Pharmaceuticals, LLCAccutest Research Laboratories (I) Pvt. Ltd.Completed
-
Organon and CoCompleted