Schizophrenia Clinical Trial
Official title:
AN OPEN-LABEL, RANDOMIZED, THREE-PERIOD, TWO-SEQUENCE CROSSOVER, REPEATED-DOSE, REPLICATE DESIGN STUDY TO DETERMINE THE BIOEQUIVALENCE OF TWO DIFFERENT LURASIDONE FORMULATIONS IN PATIENTS WITH SCHIZOPHRENIA, SCHIZOAFFECTIVE, OR SCHIZOPHRENIFORM DISORDER
Verified date | September 2011 |
Source | Sunovion |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
A Phase I, Bioequivalent Study between 2 Formulations of Lurasidone HCl
Status | Completed |
Enrollment | 52 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorders as per DSM-IV or DSM-IV-TR criteria, which in the opinion of the investigator have been clinically stable for the past 6 months. 2. Body mass index (BMI) = 19.5 and = 37 kg/m2. 3. No clinically relevant abnormal laboratory values. 4. No clinically significant findings in the 12-lead electrocardiogram (ECG): 5. No clinically significant findings from a vital signs measurement. 6. Able to understand and provide written consent prior to initiating any study procedure after being informed of the nature of the study. 7. Females who participate in this study: - are unable to have children (e.g. post-menopausal, tubal ligation, hysterectomy); OR - are willing to remain abstinent [not engage in sexual intercourse] from Day -5 until the final follow-up visit; OR - are willing to use an effective method of double-barrier birth control (e.g. partner using condom and female using diaphragm, contraceptive sponge, spermicide, or intrauterine device [IUD]) from Day -5 until the final follow-up visit. 8. Males must be willing to remain sexually abstinent or use an effective method of birth control (e.g. condom) from Day -5 until the final follow-up visit. Exclusion Criteria: 1. Significant disease(s) or clinically significant finding(s) in a physical examination determined by an Investigator to pose a health concern to the patient while on study. 2. Known history or presence of intolerance to psychiatric medications (e.g. atypical antipsychotic medications). 3. History of alcohol or drug-dependence as per DSM-IV criteria during the 6-month period immediately prior to study entry. 4. Significant orthostatic hypotension (i.e. a drop in systolic blood pressure of 30 mmHg or more and/or drop in diastolic blood pressure of 20 mmHg or more on standing). 5. Presence or history (within the last year) of a medical or surgical condition (e.g. gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone. 6. A history of epilepsy or risk of having seizures. 7. Positive test results within 30 days prior to the start of the study for: 1. Human immunodeficiency virus (HIV). 2. Hepatitis B surface antigen and Hepatitis C antibody. 3. Urine drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone). 4. Serum beta-HCG consistent with pregnancy (females only). 8. Participated in another clinical trial or received an investigational product within 30 days prior to Screening. 9. Use of any inhibitor or inducer of CYP3A4 taken within 30 days prior to check-in, including but not limited to those listed in Appendix 19.3. 10. Difficulty fasting or consuming the standard meals. 11. Females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing. -OR- Females having used implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing. 12. Donation or loss of whole blood prior to drug administration, as follows: 1. = 499 mL within 30 days prior to dosing 2. = 500 mL within 56 days prior to dosing. 13. Patient has a prolactin concentration = 100 ng/mL at Screening. |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | California Clinical Trials (CCT) | Glendale | California |
Lead Sponsor | Collaborator |
---|---|
Sunovion |
United States,
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |