Adjuvant Therapy With Pergolide in Treating Cognitive Deficits in Schizophrenia

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to compare the modulation of pergolide, a D1/D2 receptor agonist, to placebo in non-acute schizophrenic subjects under concomitant therapy with atypical antipsychotics on specific PFC functions. Further aims are to assess the influence of pergolide on psychopathology and extrapyramidal symptoms in comparison to placebo.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heidelberg University
• Collaborator: Stanley Medical Research Institute
• Treatments: Dopamine; Pergolide

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