Schizophrenia Clinical Trial
Official title:
A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of Asenapine Using Olanzapine as an Active Control in Subjects Diagnosed With Schizophrenia Who Completed Protocol P05688
Verified date | May 2015 |
Source | Forest Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Participants who have completed the 6-week trial P05688 can be screened for eligibility for this 26-week extension study in which they will continue treatment. The purpose of this trial is to evaluate the long-term safety of 2.5 and 5 mg asenapine administered sublingually twice daily (BID) in schizophrenia participants. Olanzapine administered 15 mg orally once daily (QD) is used as an active control.
Status | Completed |
Enrollment | 105 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Completed the short-term trial P05688, and judged by the investigator likely to benefit from continued treatment Exclusion Criteria: - Occurrence(s) of an adverse event or other clinically significant finding(s) in the short-term trial P05688 that would prohibit the participant's continuation into the long-term extension - Clinical Global Impression-Severity of Illness (CGI-S) score of =6 (severely psychotic) at Baseline - Newly diagnosed or discovered psychiatric condition that would have excluded the participant from participation in the short-term trial P05688 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Forest Investigative Site 2001 | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Weight From Baseline to Day 182 | Baseline (Day -1 of Short Term Trial) to Day 182 (Long-Term Extension) | Yes |
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 |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
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 |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
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 |