Therapy resistant schizophrenia Clonidine Noradrenaline
Conditions
Interventions
The main investigational product used in this study is clonidine, which is approved for the treatment of several disorders including high blood pressure, migraine and withdrawal symptoms that occur af
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
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 Inclusion criteria healthy controls: -Age between 18-45 years -Good Physical and Mental Health meeting criteria "never mentally ill", which will be evaluated with a medical history checklist; -Age between 18 and 45 years; -Written informed consent of the subject.
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. Exclusion criteria healthy controls: -Current use of any medication; -Any subject who has received any investigational medication within 30 days prior to the start of this study; -History of neurologic illness; History of psychiatric illness in first-degree relatives, evaluated with DSM-IV criteria; -History of alcohol and drug abuse; -Weight below 60 kg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in " Positive and Negative Symptom Scale (PANSS)" total compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| -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) | — |
Contacts
Public ContactM.A. Koster
UMC Utrecht
Outcome results
None listed