Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT01066403
Eligibility Criteria:
Inclusion Criteria:
* Non-acute in- and outpatients, with predominantly negative symptoms, and remitted from positive symptoms like hallucinations and delusions for 1 week, with the diagnosis of schizophrenia (ICD 10: F20) at the Psychiatry Hospital of the Universities of Heidelberg, Hamburg-Eppendorf, Zentralinstitut für Seelische Gesundheit Mannheim, SRH Klinikum Karlsbad - Langensteinbach (Clinical interview to establish diagnosis with DSM-IV (M.I.N.I International Neuropsychiatric Interview \_ German Version 5.0.0)
* Verbal IQ higher than 80, as measured by the Mehrfachwahl-Wortschatz-Intelligenztest
* Visual acuity must be normal or corrected.
* Color sight intact
* Positive neuroleptics drug monitoring level
* Females must be under adequate contraception (oral hormonal contraceptive, IntraUterineDevice)
Exclusion Criteria:
* Concomitant neurologic and internistic diseases (especially cardiovascular diseases and others like untreated thyroid hyper-/hypofunction, liver or kidney dysfunction, seizures or history of traumatic brain injury)
* Known allergy reaction under ergoline-therapy
* Actual history of drug abuse/addiction, concomitant other psychiatric disorder (screened by SCID) and suicide attempt in the medical history
* Other long term pharmacological treatment which can interact with dopamine agonists and antagonists (e.g. anticoagulants, digitoxin)
* Pregnancy and breastfeeding (anamneses and pregnancy test in urine)
* Participation in other clinical trial for the last 3 months
* History of malignant neuroleptic syndrome
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01066403
Study Brief:
Protocol Section:
NCT01066403