A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia

• Sponsor: Mitsubishi Tanabe Pharma Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01626885
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arm: 1
• Duration (Months): 25
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with receiving multiple drugs schizophrenia.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: MP-214	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MP-214 1.5-9 mg	Drug: MP-214; Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [Up to 60 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Written informed consent obtained from the patient before the initiation of any study-specific procedures

• Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia

• Patients who receive 1 or more antipsychotic drugs

• Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria:

• Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Kurayoshi	Tottori	Japan

Sponsors and Collaborators

• Mitsubishi Tanabe Pharma Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mitsubishi Tanabe Pharma Corporation
• ClinicalTrials.gov Identifier: NCT01626885
• Other Study ID Numbers: A002-A8
• First Posted: Jun 25, 2012
• Last Update Posted: Apr 13, 2021
• Last Verified: Apr 1, 2021

• Keywords provided by Mitsubishi Tanabe Pharma Corporation: Schizophrenia; Antipsychotic Agents; Mental Disorder; Psychotropic Drugs; Dopamine Agents; Central Nervous System Agents
• Additional relevant MeSH terms: Schizophrenia

Study Results

Participant Flow

Arm/Group Title	MP-214 1.5-9 mg
Arm/Group Description	MP-214: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214
Period Title: Overall Study
STARTED	42
COMPLETED	30
NOT COMPLETED	12

Baseline Characteristics

Arm/Group Title	MP-214 1.5-9 mg
Arm/Group Description	MP-214: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214
Overall Participants	42
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.4 (10.7)
Sex: Female, Male (Count of Participants)
Female	19 45.2%
Male	23 54.8%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame	Up to 60 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MP-214 1.5-9 mg
Arm/Group Description	MP-214: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214
Measure Participants	42
Count of Participants [Participants]	42 100%

Adverse Events

Arm/Group Title	MP-214 1.5-9 mg
Arm/Group Description	MP-214: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214
All Cause Mortality
	MP-214 1.5-9 mg
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	MP-214 1.5-9 mg
	Affected / at Risk (%)	# Events
Total	2/42 (4.8%)
Metabolism and nutrition disorders
Type 2 diabetes mellitus	1/42 (2.4%)
Psychiatric disorders
Schizophrenia	1/42 (2.4%)
Other (Not Including Serious) Adverse Events
	MP-214 1.5-9 mg
	Affected / at Risk (%)	# Events
Total	37/42 (88.1%)
Gastrointestinal disorders
Nausea	4/42 (9.5%)
Vomiting	3/42 (7.1%)
Infections and infestations
Nasopharyngitis	18/42 (42.9%)
Injury, poisoning and procedural complications
Contusion	3/42 (7.1%)
Investigations
Alanine aminotransferase increased	5/42 (11.9%)
Aspartate aminotransferase increased	3/42 (7.1%)
Blood creatine phosphokinase increased	6/42 (14.3%)
Gamma-glutamyltransferase increased	3/42 (7.1%)
Weight increased	6/42 (14.3%)
Musculoskeletal and connective tissue disorders
Back pain	3/42 (7.1%)
Nervous system disorders
Akathisia	3/42 (7.1%)
Dizziness	3/42 (7.1%)
Extrapyramidal disorder	6/42 (14.3%)
Headache	7/42 (16.7%)
Somnolence	7/42 (16.7%)
Psychiatric disorders
Anxiety	3/42 (7.1%)
Initial insomnia	3/42 (7.1%)
Insomnia	5/42 (11.9%)
Irritability	3/42 (7.1%)
Schizophrenia	8/42 (19%)
Respiratory, thoracic and mediastinal disorders
Asthma	3/42 (7.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.