Adjuvant Therapy With Pergolide in Treating Cognitive Deficits in Schizophrenia
Dopaminergic Modulation of Prefrontal Functions in Schizophrenic Patients: Adjuvant Therapy With Pergolide
1 other identifier
interventional
28
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable schizophrenia
Started Oct 2003
Typical duration for not_applicable schizophrenia
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 9, 2010
CompletedFirst Posted
Study publicly available on registry
February 10, 2010
CompletedFebruary 10, 2010
December 1, 2008
4.4 years
February 9, 2010
February 9, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The D1-specific dopaminergic modulation of prefrontal functions (executive control, working memory, control of semantic association) confirmed by a complex neuropsychological battery including a non - PFC activating control task
30 days
Secondary Outcomes (1)
Influence of pergolide on psychopathology symptoms and extrapyramidal symptoms in comparison to placebo measured by specific rating scales, e.g. PANSS and Calgary Depression Scale
30 days
Study Arms (1)
Pergolide
EXPERIMENTALPatients will be randomly assigned to a sequence of treatments of either pergolide or placebo p.o. under continuous concomitant atypical neuroleptic therapy (stable at least 2 weeks prior trial begin).
Interventions
0,3 mg pergolide (the first two days begin with 0,05mg, then increase of dose of 0,1mg every 3 days for a maximum of 0,3mg/d, taken orally 3x 0,1mg/day). Then stable dose of 0,3mg for one week.. Subsequently slow (for 8 days) reduction of dosage of 0,1mg every 3 days for 6 days then 0,05mg every day for the last two days. Placebo group is identical in appearance and number of placebo capsules, in the same starting and maintenance scheme as for the pergolide group.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Heidelberg Universitylead
- Stanley Medical Research Institutecollaborator
Study Sites (4)
Zentralinstitut für Seelische Gesundheit
Mannheim, 68159, Germany
Psychiatrische Universitätsklinik
Heidelberg, Baden-Wurttemberg, 69115, Germany
Universitätsklinikum Hamburg - Eppendorf
Hamburg, 20246, Germany
SRH Klinikum Karlsbad - Langensteinbach gGmbH
Karlsbad, 76307, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniela Roesch - Ely, MD
Psychiatrische Universitätsklinik Heidelberg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 9, 2010
First Posted
February 10, 2010
Study Start
October 1, 2003
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
February 10, 2010
Record last verified: 2008-12