NL-OMON43400
Completed
Phase 3
A 52-Week, Open-Label, Prospective, Multicenter, International Study of a Transition to the Paliperidone Palmitate 3-Month Formulation In Patients with Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation. - REMISSIO
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Schizofrenia
- Sponsor
- Janssen-Cilag
- Enrollment
- 6
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Meets Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM\-5\) criteria for a diagnosis of schizophrenia
- •\* Able to read, understand, and sign the informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
- •\* Willing and able to fill out self\-administered questionnaires
- •\* Willing and able to adhere to the prohibitions and restrictions specified in the protocol
- •\* A woman of childbearing potential must have a negative urine pregnancy test at Screening and baseline
- •\* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study drug
Exclusion Criteria
- •\* His/her psychiatric diagnosis is due to direct pharmacological effects of a substance (example, a drug of abuse or medication) or a general medical condition (example, clinically notable hypothyroidism, organic brain disorder)
- •\*has a current DSM\-5 diagnosis of dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, autistic disorder, or intellectual disabilities and/or meets the DSM\-5 definition of moderate to severe substance use disorder (except for nicotine or caffeine) within 6 months prior to screening. However, subjects with mild or moderate substance use disorder, with the exception of intravenous drug use, will be eligible for enrollment.
- •\* Experienced intolerable side effects during treatment with paliperidone palmitate 1\-month formulation (PP1M)
- •\* Has a known hypersensitivity to paliperidone or risperidone
- •\* Has received any other long\-acting injectable antipsychotic medication other than PP1M within the last 4 months before the first injection of the study drug paliperidone palmitate 3\-month formulation (PP3M)
- •\* Has received clozapine during the last 3 months before the Screening visit.
- •\* Is considered to be at imminent risk of suicide, even after clinical intervention
- •\* Has a serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities
- •\* Has a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome
- •\* Is a woman who is pregnant or breast\-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of PP3M
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 4
A Multi Center, Prospective, Observational, Open-label, Pharmacokinetic Study of Tacrolimus in Heart and Lung Transplantation Patients during the First Days after TransplantatioHeart and lung transplantation100192801003868610038716NL-OMON39373niversitair Medisch Centrum Utrecht30
Completed
Phase 2
A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Administration of ALN-GO1 in Patients with Primary Hyperoxaluria Type 1.Primary Hyperoxaluria Type 1metabolic disorders10038430NL-OMON50391Alnylam Pharmaceuticals, Inc2
Completed
Not Applicable
A Prospective, Multicenter, Open Label, Single Arm, Study to Assess the Safety & Performance of the Harmony Aortic Stimulation System (HASS) for the Treatment of Heart FailureCardiac FailureHeart Failure10019280NL-OMON51726van de Wetering CRC2
Recruiting
Phase 2
An Open- Label, Phase 2, Multicenter Feasibility Study if Manualized MDMA-Assisted Psychotherapy with an fMRI sub-study Assessing Changes in Brain Activity in Subjects with Post-Traumatic Stress DisorderNL-OMON56347MAPS Europe B.V.8
Completed
Phase 2
A randomized, open-label, parallel-group, multi-center study of adding edoxaban or clopidogrel to aspirin to maintain patency in subjects with peripheral arterial disease following femoropopliteal endovascular intervention-edoxaban in peripheral arterial disease (ePAD)narrowing of the peripheral arteries (mostly in the legs)periferal arterial disease10003216NL-OMON40071Daiichi Sankyo Development Ltd14