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

NCT04975035 | Terminated Phase 1

• 1 other identifier: 2012-074
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (3)

• score of PANSS

  the score of positive and negative syndrome scale (PANSS), the minimum and maximum values are 16 and 112, the higher scores mean a worse outcome.

  2 weeks

• score of HAMA

  the score of Hamilton anxiety scale(HAMA), the minimum and maximum values are 0 and 56, the higher scores mean a worse outcome.

  2 weeks

• score of HAMD

  the score of Hamilton depression scale(HAMD), the minimum and maximum values are 0 and 68, the higher scores mean a worse outcome.

  2 weeks

Study Arms (1)

Zolodine group

EXPERIMENTAL

Drug: Zolodine

Interventions

Zolodine DRUG

Collect 200 patients who meet the criteria into the group. After enrollment, according to the principle of cross dressing change, the attending physician can decide the dressing change method according to the patient's condition, individual condition and other factors; within 2-4 weeks, the original antipsychotics should be gradually stopped, and Zoladine capsules will be gradually added to the target The dose is 120-160mg/d, orally 1-2 times a day, with meals.

Zolodine group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2021
• First Posted: July 23, 2021
• Study Start: January 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 23, 2021

Record last verified: 2012-06