Schizophrenia, schizophreniform disorder, schizoaffective disorder
Conditions
Interventions
Trade Name: Clonidine HCL
Product Name: Clonidine HCL
Product Code: RVG nr: 19845=56917
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo:
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A DSM-IV-R diagnosis of: 295.x (schizophrenia, schizophreniform disorder, or schizoaffective disorder) 2. No or only partial response to clozapine as defined by a total PANSS score of at least 80. 3. Age 18-45 years. 4. Patients are treated with antipsychotic medication 5. Written informed consent 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 75 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Presence of any of the contra-indications of clonidine as reported in the Summary of Product Characteristics (SPC). 2. Supine systolic blood pressure (SSBP) 20 mmHg or a drop of diastolic blood pressure of >10 mmHg. 4. Supine heart rate (SHR) < 50 beats/min 5. Severe brady-arhytmias such as sick-sinussyndroom, second or third degree AV-block. 6. Pregnancy or breast-feeding. A urine pregnancy test will be performed at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim is to investigate whether six weeks augmentation with clonidine of the antipsychotic treatment will reduce positive and negative symptomatology of treatment resistant schizophrenia patients. ;Secondary Objective: Secondary goals of this project are to determine whether this treatment will improve cognitive functioning and daily functioning in these treatment resistant schizophrenia patients. Also, parameters of basic information processing, measured with EEG will be assessed as a secondary outcome. -General functioning (tested by "Global Assessment of Functioning", GAF) -Cognitive functioning (tested by "Brief Assessment in Cognition", BACS and "The Cambridge Neuropsychological Test Automated Battery", CANTAB) -Depressive symptoms (tested by "Calgary Depression Scale For Schizophrenia", CDSS) -Safety data will be evaluated by comparing incidences (number and percentage of subjects with at least one occurrence) of key SEAs and SUSARs (e.g. hospitalizations) -Psychophysiological parameters (tested by "Copenhagen Psychophysiological Test Battery", CPTB) ;Primary end point(s): Change in total score on the Positive and Negative Symptom Scale (PANSS) from baseline to endpoint (6 weeks);Timepoint(s) of evaluation of this end point: PANSS will be measured at baseline, halftime (3 weeks after baseline) and at the end (6 weeks after baseline) of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary objectives concern the comparison of the 2 groups with regards to changed in: -General functioning (tested by "Global Assessment of Functioning", GAF) -Cognitive functioning (tested by "Brief Assessment in Cognition", BACS and "The Cambridge Neuropsychological Test Automated Battery", CANTAB) -Depressive symptoms (tested by "Calgary Depression Scale For Schizophrenia", CDSS) -Safety data will be evaluated by comparing incidences (number and percentage of subjects with at least one occurrence) of key SEAs and SUSARs (e.g. hospitalizations) -Psychophysiological parameters (tested by "Copenhagen Psychophysiological Test Battery", CPTB) ;Timepoint(s) of evaluation of this end point: BACS: Baseline and final (6 weeks after baseline) visit CANTAB: Baseline and final (6 weeks after baseline) visit GAF: Baseline and final (6 weeks after baseline) visit. CPTB: Baseline, halftime (3 weeks after baseline) and final (6 weeks after baseline) visit CDSS: Baseline, halftime (3 weeks after baseline) and final (6 weeks after baseline) visit | — |
Countries
Netherlands
Contacts
Public Contactb.oranje-2@umcutrecht.nl
University Medical Center Utrecht
Outcome results
None listed