Trial Outcomes & Findings for 40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786) (NCT NCT00145509)
NCT ID: NCT00145509
Last Updated: 2022-02-08
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
77 participants
Primary outcome timeframe
up to 52 weeks
Results posted on
2022-02-08
Participant Flow
Participant milestones
| Measure |
Asenapine
Asenapine 5 or 10 mg sublingually twice daily (BID)
|
Placebo
Placebo sublingually BID
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
36
|
|
Overall Study
COMPLETED
|
19
|
15
|
|
Overall Study
NOT COMPLETED
|
22
|
21
|
Reasons for withdrawal
| Measure |
Asenapine
Asenapine 5 or 10 mg sublingually twice daily (BID)
|
Placebo
Placebo sublingually BID
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
3
|
|
Overall Study
Lack of Efficacy
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
9
|
|
Overall Study
Withdrew Consent
|
2
|
7
|
|
Overall Study
Reason not provided
|
2
|
1
|
Baseline Characteristics
40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)
Baseline characteristics by cohort
| Measure |
Asenapine
n=41 Participants
Asenapine 5 or 10 mg sublingually twice daily (BID)
|
Placebo
n=36 Participants
Placebo sublingually BID
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 11.79 • n=99 Participants
|
38.7 years
STANDARD_DEVIATION 13.42 • n=107 Participants
|
38.9 years
STANDARD_DEVIATION 12.49 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 52 weeksParticipants 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).
Outcome measures
| Measure |
Asenapine
n=41 Participants
Asenapine 5 or 10 mg sublingually twice daily (BID)
|
Placebo
n=36 Participants
Placebo sublingually BID
|
|---|---|---|
|
Number of Participants Who Experienced an Adverse Event
|
32 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: 40 weeksParticipants who discontinued study medication due to adverse events.
Outcome measures
| Measure |
Asenapine
n=41 Participants
Asenapine 5 or 10 mg sublingually twice daily (BID)
|
Placebo
n=36 Participants
Placebo sublingually BID
|
|---|---|---|
|
Number of Participants Who Discontinued Because of an Adverse Event
|
10 participants
|
3 participants
|
PRIMARY outcome
Timeframe: Baseline and 52 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
Asenapine
n=38 Participants
Asenapine 5 or 10 mg sublingually twice daily (BID)
|
Placebo
n=33 Participants
Placebo sublingually BID
|
|---|---|---|
|
Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score
|
-17.2 Score on a Scale
Standard Deviation 13.65
|
-19.7 Score on a Scale
Standard Deviation 11.81
|
PRIMARY outcome
Timeframe: Baseline and 52 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
Asenapine
n=38 Participants
Asenapine 5 or 10 mg sublingually twice daily (BID)
|
Placebo
n=33 Participants
Placebo sublingually BID
|
|---|---|---|
|
Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score
|
-3.3 Score on a scale
Standard Deviation 9.75
|
-3.9 Score on a scale
Standard Deviation 7.71
|
Adverse Events
Asenapine
Serious events: 9 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Asenapine
n=41 participants at risk
Asenapine 5 or 10 mg sublingually twice daily (BID)
|
Placebo
n=36 participants at risk
Placebo sublingually BID
|
|---|---|---|
|
Injury, poisoning and procedural complications
INTENTIONAL OVERDOSE
|
2.4%
1/41 • Number of events 1
|
0.00%
0/36
|
|
Nervous system disorders
EXTRAPYRAMIDAL DISORDER
|
2.4%
1/41 • Number of events 1
|
0.00%
0/36
|
|
Psychiatric disorders
BIPOLAR I DISORDER
|
0.00%
0/41
|
2.8%
1/36 • Number of events 3
|
|
Psychiatric disorders
DEPRESSION
|
2.4%
1/41 • Number of events 1
|
0.00%
0/36
|
|
Psychiatric disorders
DEPRESSIVE SYMPTOM
|
2.4%
1/41 • Number of events 1
|
0.00%
0/36
|
|
Psychiatric disorders
MANIA
|
9.8%
4/41 • Number of events 4
|
11.1%
4/36 • Number of events 4
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
2.4%
1/41 • Number of events 1
|
0.00%
0/36
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
4.9%
2/41 • Number of events 3
|
0.00%
0/36
|
Other adverse events
| Measure |
Asenapine
n=41 participants at risk
Asenapine 5 or 10 mg sublingually twice daily (BID)
|
Placebo
n=36 participants at risk
Placebo sublingually BID
|
|---|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
9.8%
4/41 • Number of events 8
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHOEA
|
4.9%
2/41 • Number of events 2
|
13.9%
5/36 • Number of events 5
|
|
Gastrointestinal disorders
DRY MOUTH
|
7.3%
3/41 • Number of events 3
|
8.3%
3/36 • Number of events 3
|
|
Gastrointestinal disorders
HYPOAESTHESIA ORAL
|
7.3%
3/41 • Number of events 3
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
7.3%
3/41 • Number of events 4
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
VOMITING
|
9.8%
4/41 • Number of events 4
|
5.6%
2/36 • Number of events 3
|
|
General disorders
IRRITABILITY
|
7.3%
3/41 • Number of events 3
|
2.8%
1/36 • Number of events 1
|
|
General disorders
PYREXIA
|
0.00%
0/41
|
5.6%
2/36 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.4%
1/41 • Number of events 1
|
8.3%
3/36 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
4.9%
2/41 • Number of events 5
|
5.6%
2/36 • Number of events 2
|
|
Nervous system disorders
DIZZINESS
|
4.9%
2/41 • Number of events 2
|
5.6%
2/36 • Number of events 3
|
|
Nervous system disorders
DYSKINESIA
|
7.3%
3/41 • Number of events 4
|
0.00%
0/36
|
|
Nervous system disorders
HEADACHE
|
19.5%
8/41 • Number of events 11
|
16.7%
6/36 • Number of events 7
|
|
Nervous system disorders
PARKINSONISM
|
2.4%
1/41 • Number of events 2
|
5.6%
2/36 • Number of events 3
|
|
Nervous system disorders
SEDATION
|
14.6%
6/41 • Number of events 8
|
5.6%
2/36 • Number of events 2
|
|
Nervous system disorders
SOMNOLENCE
|
14.6%
6/41 • Number of events 7
|
8.3%
3/36 • Number of events 4
|
|
Nervous system disorders
TREMOR
|
7.3%
3/41 • Number of events 5
|
8.3%
3/36 • Number of events 3
|
|
Psychiatric disorders
ANXIETY
|
9.8%
4/41 • Number of events 4
|
11.1%
4/36 • Number of events 11
|
|
Psychiatric disorders
DEPRESSION
|
2.4%
1/41 • Number of events 1
|
5.6%
2/36 • Number of events 3
|
|
Psychiatric disorders
INSOMNIA
|
19.5%
8/41 • Number of events 10
|
13.9%
5/36 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
2.4%
1/41 • Number of events 1
|
8.3%
3/36 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
4.9%
2/41 • Number of events 2
|
8.3%
3/36 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
RASH
|
4.9%
2/41 • Number of events 3
|
5.6%
2/36 • Number of events 2
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institution will provide manuscripts, abstracts, or the full text of any other intended disclosure to the sponsor at least 30 days prior to submission for publication or other disclosure. If any patent action is required to protect intellectual property rights, Institution agrees to delay the disclosure for a period not to exceed and additional 60 days. Institution will, on request, remove any previously undisclosed Confidential Information (other than study results) before disclosure.
- Publication restrictions are in place
Restriction type: OTHER