Schizophrenia MedDRA version: 14.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Haloperidol 1.5 mg tablet
Pharmaceutical Form: Tablet
INN or Proposed INN: haloperidol
CAS Number: 52-86-8
Current Sponsor code: haloperidol
Other descriptive name: HALOPERIDOL
Concentrati
Sponsors
Universität Bremen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key inclusion criteria: Patients with schizophrenia, age 18-65, necessity to establish new or change antipsychotic treatment due to unsatisfying results or side effects. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 630 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Key exclusion criteria: Acute suicidal tendency, “Einwilligungsvorbehalt (BGB)” or “Unterbringung (PsychKG)“, organic psychosis, history of malignant neuroleptic syndrome, QTc interval = 0.5s / history of congenital QTc prolongation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Contentment with treatment in 1) patients and 2) psychiatrists; Patient: SF-36 (interviewer version with a time frame of one week); Psychiatrist: CGI. ;Secondary Objective: Subscores of SF-36, SWN-K, PSP, PANSS, matrics (selected centres). Assessment of safety: Adverse events, drop-out rates, SAS / AIMS / BARS and sexual dysfunction changes. Metabolic side effects: body mass index (BMI), waist circumference, HbA1c, fast blood glucose levels, lipid profile. ;Primary end point(s): Primary efficacy endpoint: Contentment with treatment in 1) patients and 2) psychiatrists; Patient: SF-36 (interviewer version with a time frame of one week); Psychiatrist: CGI. ;Timepoint(s) of evaluation of this end point: Baseline and 2, 4, 6, 12, 24 weeks after patient inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Subscores of SF-36 (AUC, logtime) - SWN-K - PSP (family member rating, rating by oneself, family member questionnaire) - PANSS ;Timepoint(s) of evaluation of this end point: Baseline and 6, 24 weeks after patient inclusion | — |
Countries
Germany
Contacts
Public ContactClinical Trials Information
Universität Bremen
Outcome results
None listed