A Prospective, Open-ended, Multi-center Study of Schizophrenia Patients Switching to Zolodine

Zhejiang University

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Schizophrenia

Treatments

Drug: Zolodine

Study type

Interventional

Funder types

Other

Identifiers

NCT04975035

2012-074

Details and patient eligibility

About

Through self-controlled studies on metabolic syndrome related indicators, efficacy and other adverse reactions in patients with schizophrenia who developed metabolic syndrome after treatment with other antipsychotics, switched to Zoladine capsules (ziprasidone hydrochloride capsules). To evaluate the clinical application value of switching to Zolodine for schizophrenia patients with metabolic syndrome, and to explore the drug selection strategy for long-term treatment of schizophrenia patients.

Enrollment

200 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Meet the DSM-IV diagnostic criteria for schizophrenia, patients aged 18-40 years old have been treated with other antipsychotics for more than 8 weeks (inclusive) before being included, meet the diagnostic criteria for metabolic syndrome (IDF, 2005), and have not reached diabetes , Patients with diagnostic criteria for hypertension.

Exclusion criteria

Female patients who are pregnant or breastfeeding;
Serious and unstable physical diseases, including: cardiovascular, respiratory, liver, kidney, gastrointestinal, nerve, endocrine, immune, blood system, narrow-angle glaucoma, history of seizures;
Patients with refractory schizophrenia;
Those who meet the DSM-IV standards for dementia or substance dependence (except tobacco);
Patients with a history of contraindications to ziprasidone or intolerance of ziprasidone;
Patients who use long-acting antipsychotic injections or oral medications;
Patients who have recently experienced prolonged QT interval, acute myocardial infarction, and decompensated heart failure;
Patients have recently taken drugs that can prolong the QT interval, such as dofetilide, sotalol, quinidine, other class Ia and III antiarrhythmic drugs, mesoridazine, thioridazine, Chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadone, dolastron methanesulfonate Acid, probucol or tacrolimus;
At the same time taking other drugs that can cause obesity, such as oral contraceptives;
Patients who have met metabolic syndrome before diagnosis and treatment of schizophrenia.