Trial Outcomes & Findings for Safety and Efficacy of MP-214 in Patients With Schizophrenia (NCT NCT01625000)
NCT ID: NCT01625000
Last Updated: 2026-01-05
Results Overview
PANSS score is a 30-item rating scale to assess both the positive and negative symptom syndromes of patients with schizophrenia. Each item is scored on a 7-point scale, from 1 (absent) to 7 (extreme). The PANSS total score of the 30 PANSS items ranges from 30 to 210. High scores indicate greater severity of symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
512 participants
Primary outcome timeframe
Baseline and Week 6
Results posted on
2026-01-05
Participant Flow
Four subjects withdrew from the study before the start of the study medication after being assigned to the treatment.
Participant milestones
| Measure |
MP-214 3mg
MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.
|
MP-214 6mg
MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.
|
MP-214 9mg
MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.
|
Risperidone 4mg
Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
|
Placebo
Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
126
|
133
|
67
|
56
|
126
|
|
Overall Study
COMPLETED
|
74
|
81
|
34
|
37
|
71
|
|
Overall Study
NOT COMPLETED
|
52
|
52
|
33
|
19
|
55
|
Reasons for withdrawal
| Measure |
MP-214 3mg
MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.
|
MP-214 6mg
MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.
|
MP-214 9mg
MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.
|
Risperidone 4mg
Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
|
Placebo
Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
15
|
7
|
7
|
2
|
15
|
|
Overall Study
Protocol Violation
|
3
|
10
|
4
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
19
|
16
|
11
|
9
|
17
|
|
Overall Study
Adverse Event (including Death)
|
15
|
19
|
11
|
7
|
21
|
Baseline Characteristics
Safety and Efficacy of MP-214 in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
MP-214 3mg
n=126 Participants
MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.
|
MP-214 6mg
n=133 Participants
MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.
|
MP-214 9mg
n=67 Participants
MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.
|
Risperidone 4mg
n=56 Participants
Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
|
Placebo
n=126 Participants
Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
|
Total
n=508 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 10.6 • n=9667 Participants
|
40.2 years
STANDARD_DEVIATION 11.4 • n=6597 Participants
|
43.0 years
STANDARD_DEVIATION 9.7 • n=16264 Participants
|
39.5 years
STANDARD_DEVIATION 10.2 • n=31 Participants
|
40.1 years
STANDARD_DEVIATION 11.1 • n=21 Participants
|
40.6 years
STANDARD_DEVIATION 10.8 • n=3 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=9667 Participants
|
60 Participants
n=6597 Participants
|
34 Participants
n=16264 Participants
|
25 Participants
n=31 Participants
|
66 Participants
n=21 Participants
|
245 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=9667 Participants
|
73 Participants
n=6597 Participants
|
33 Participants
n=16264 Participants
|
31 Participants
n=31 Participants
|
60 Participants
n=21 Participants
|
263 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: For OC (Observed Case) analysis, the Missing Values were Not included.
PANSS score is a 30-item rating scale to assess both the positive and negative symptom syndromes of patients with schizophrenia. Each item is scored on a 7-point scale, from 1 (absent) to 7 (extreme). The PANSS total score of the 30 PANSS items ranges from 30 to 210. High scores indicate greater severity of symptoms.
Outcome measures
| Measure |
MP-214 3mg
n=78 Participants
MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.
|
MP-214 6mg
n=80 Participants
MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.
|
MP-214 9mg
n=36 Participants
MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.
|
Risperidone 4mg
n=36 Participants
Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
|
Placebo
n=71 Participants
Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
|
|---|---|---|---|---|---|
|
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
|
-10.4 units on a scale
Standard Error 2.0
|
-13.8 units on a scale
Standard Error 2.0
|
-14.0 units on a scale
Standard Error 2.9
|
-20.2 units on a scale
Standard Error 3.0
|
-9.5 units on a scale
Standard Error 2.1
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: For OC (Observed Case) analysis, the Missing Values were Not included.
CGI-S is a 7-point scale to assess the global severity of the participant's illness. CGI-S scores range from 1 (normal, not ill at all) to 7 (extremely ill).
Outcome measures
| Measure |
MP-214 3mg
n=78 Participants
MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.
|
MP-214 6mg
n=80 Participants
MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.
|
MP-214 9mg
n=36 Participants
MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.
|
Risperidone 4mg
n=36 Participants
Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
|
Placebo
n=71 Participants
Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
|
|---|---|---|---|---|---|
|
Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6
|
-0.7 units on a scale
Standard Error 0.1
|
-0.8 units on a scale
Standard Error 0.1
|
-0.7 units on a scale
Standard Error 0.2
|
-1.2 units on a scale
Standard Error 0.2
|
-0.6 units on a scale
Standard Error 0.1
|
Adverse Events
MP-214 3mg
Serious events: 12 serious events
Other events: 95 other events
Deaths: 0 deaths
MP-214 6mg
Serious events: 16 serious events
Other events: 100 other events
Deaths: 0 deaths
MP-214 9mg
Serious events: 4 serious events
Other events: 52 other events
Deaths: 0 deaths
Risperidone 4mg
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
Placebo
Serious events: 14 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MP-214 3mg
n=126 participants at risk
MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.
|
MP-214 6mg
n=133 participants at risk
MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.
|
MP-214 9mg
n=67 participants at risk
MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.
|
Risperidone 4mg
n=56 participants at risk
Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
|
Placebo
n=126 participants at risk
Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
|
|---|---|---|---|---|---|
|
General disorders
Sudden death
|
0.00%
0/126
|
0.75%
1/133
|
0.00%
0/67
|
0.00%
0/56
|
0.00%
0/126
|
|
Infections and infestations
Infection masked
|
0.00%
0/126
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/56
|
0.79%
1/126
|
|
Infections and infestations
Pneumonia
|
0.79%
1/126
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/56
|
0.00%
0/126
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/126
|
0.75%
1/133
|
0.00%
0/67
|
0.00%
0/56
|
0.00%
0/126
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/126
|
0.75%
1/133
|
0.00%
0/67
|
0.00%
0/56
|
0.00%
0/126
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.79%
1/126
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/56
|
0.00%
0/126
|
|
Nervous system disorders
Akathisia
|
0.00%
0/126
|
0.00%
0/133
|
0.00%
0/67
|
1.8%
1/56
|
0.00%
0/126
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/126
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/56
|
0.79%
1/126
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/126
|
0.00%
0/133
|
0.00%
0/67
|
1.8%
1/56
|
0.00%
0/126
|
|
Nervous system disorders
Neuroleptic malignant syndrome
|
0.00%
0/126
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/56
|
0.79%
1/126
|
|
Psychiatric disorders
Agitation
|
0.00%
0/126
|
0.00%
0/133
|
1.5%
1/67
|
0.00%
0/56
|
0.00%
0/126
|
|
Psychiatric disorders
Schizophrenia
|
7.1%
9/126
|
10.5%
14/133
|
4.5%
3/67
|
0.00%
0/56
|
9.5%
12/126
|
|
Psychiatric disorders
Suicidal behaviour
|
0.00%
0/126
|
0.00%
0/133
|
1.5%
1/67
|
0.00%
0/56
|
0.00%
0/126
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/126
|
0.00%
0/133
|
1.5%
1/67
|
0.00%
0/56
|
0.00%
0/126
|
|
Psychiatric disorders
Suicide attempt
|
0.79%
1/126
|
0.00%
0/133
|
0.00%
0/67
|
1.8%
1/56
|
0.79%
1/126
|
Other adverse events
| Measure |
MP-214 3mg
n=126 participants at risk
MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.
|
MP-214 6mg
n=133 participants at risk
MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.
|
MP-214 9mg
n=67 participants at risk
MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.
|
Risperidone 4mg
n=56 participants at risk
Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
|
Placebo
n=126 participants at risk
Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.9%
10/126
|
11.3%
15/133
|
13.4%
9/67
|
14.3%
8/56
|
4.8%
6/126
|
|
Injury, poisoning and procedural complications
Contusion
|
3.2%
4/126
|
2.3%
3/133
|
3.0%
2/67
|
3.6%
2/56
|
6.3%
8/126
|
|
Investigations
Blood creatine phosphokinase increased
|
5.6%
7/126
|
3.8%
5/133
|
0.00%
0/67
|
3.6%
2/56
|
4.0%
5/126
|
|
Investigations
Liver function test abnormal
|
0.79%
1/126
|
0.75%
1/133
|
7.5%
5/67
|
0.00%
0/56
|
0.79%
1/126
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.8%
6/126
|
5.3%
7/133
|
3.0%
2/67
|
0.00%
0/56
|
3.2%
4/126
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.6%
2/126
|
0.75%
1/133
|
3.0%
2/67
|
5.4%
3/56
|
0.79%
1/126
|
|
Nervous system disorders
Akathisia
|
22.2%
28/126
|
14.3%
19/133
|
3.0%
2/67
|
16.1%
9/56
|
7.9%
10/126
|
|
Nervous system disorders
Dizziness
|
3.2%
4/126
|
4.5%
6/133
|
4.5%
3/67
|
7.1%
4/56
|
3.2%
4/126
|
|
Nervous system disorders
Extrapyramidal disorder
|
8.7%
11/126
|
14.3%
19/133
|
16.4%
11/67
|
10.7%
6/56
|
9.5%
12/126
|
|
Nervous system disorders
Headache
|
15.1%
19/126
|
10.5%
14/133
|
10.4%
7/67
|
7.1%
4/56
|
11.1%
14/126
|
|
Nervous system disorders
Somnolence
|
2.4%
3/126
|
1.5%
2/133
|
7.5%
5/67
|
1.8%
1/56
|
2.4%
3/126
|
|
Nervous system disorders
Tremor
|
5.6%
7/126
|
9.8%
13/133
|
1.5%
1/67
|
0.00%
0/56
|
3.2%
4/126
|
|
Psychiatric disorders
Insomnia
|
9.5%
12/126
|
12.0%
16/133
|
7.5%
5/67
|
3.6%
2/56
|
7.1%
9/126
|
|
Psychiatric disorders
Restlessness
|
2.4%
3/126
|
3.8%
5/133
|
6.0%
4/67
|
5.4%
3/56
|
4.0%
5/126
|
|
Psychiatric disorders
Schizophrenia
|
12.7%
16/126
|
11.3%
15/133
|
19.4%
13/67
|
12.5%
7/56
|
18.3%
23/126
|
|
Vascular disorders
Hypertension
|
0.00%
0/126
|
3.8%
5/133
|
9.0%
6/67
|
0.00%
0/56
|
1.6%
2/126
|
|
Gastrointestinal disorders
Nausea
|
11.9%
15/126
|
6.8%
9/133
|
10.4%
7/67
|
7.1%
4/56
|
4.0%
5/126
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
18/126
|
9.0%
12/133
|
7.5%
5/67
|
1.8%
1/56
|
5.6%
7/126
|
|
Gastrointestinal disorders
Constipation
|
16.7%
21/126
|
15.0%
20/133
|
17.9%
12/67
|
8.9%
5/56
|
11.9%
15/126
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
6/126
|
6.0%
8/133
|
6.0%
4/67
|
1.8%
1/56
|
2.4%
3/126
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
3/126
|
3.0%
4/133
|
6.0%
4/67
|
3.6%
2/56
|
2.4%
3/126
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER