Clonidine Augmentation Treatment in Schizophrenia

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 75

Inclusion Criteria

1. A DSM-IV-R diagnosis of: 295.x (schizophrenia), schizophreniform disorder, or schizoaffective disorder)
3. A total PANSS score of at least 55
4. Age 18-50 years.
5. Patients are treated with antipsychotic medication
6. Written informed consent
7. Female patients of childbearing potential need to utilize a proper method of contraception
8. (oral anticonceptives, vaginal ring, hormonal patch, intrauterine device, cervical cap, condom, contraceptive injection, diaphragm) in case of sexual intercourse during the study.
Ad. A priority will be given to patients who achieve no or only partial response to clozapine as defined by a total PANSS score of at least 80.;Inclusion criteria healthy controls:
-Age between 18-50 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

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) < 85 mm HG
3. Pre-existent orthostatic hypotension with a drop of systolic blood pressure of > 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.
7. The use of drugs that affect the (nor)adrenergic system such as beta-blockes and mirtazapine.;Exclusion criteria healthy controls:
-Current use of any medication prescribed medication exclusive oral anticonceptives;
-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;
-BMI below 18.5.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in Positive and Negative Symptom Scale (PANSS) total compared to<br /><br>baseline. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-General functioning (tested by Global Assessment of Functioning, GAF)<br /><br>-Cognitive functioning (tested by Brief Assessment in Cognition, BACS and<br /><br>The Cambridge Neuropsychological Test Automated Battery, CANTAB)<br /><br>-IQ assessment (tested by vocabulary and block design subsets of the Wechsler<br /><br>Adult Intelligence Scale (WAIS) and the Trail Making Test A & B)<br /><br>-Depressive symptoms (tested by Calgary Depression Scale For Schizophrenia,<br /><br>CDSS)<br /><br>-Safety data will be evaluated by comparing incidences (number and percentage<br /><br>of subjects with at least one occurrence) of key SEAs and SUSARs (e.g.<br /><br>hospitalizations)<br /><br>-Psychophysiological parameters (tested by Copenhagen Psychophysiological Test<br /><br>Battery, CPTB)</p><br>