An Early Phase 1 interventional study of 200 mg levodopa/50 mg benserazide and Dextrose in Healthy and Schizotypal Personality, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to male participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by University of Zurich · Early Phase 1, Interventional, and Basic science
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The dopamine hypothesis of schizophrenia implies that alterations in the dopamine system cause functional abnormalities in the brain that may converge to aberrant salience attribution and eventually lead to psychosis. Indeed, widespread brain disconnectivity across the psychotic spectrum has been revealed by resting-state functional magnetic resonance imaging (rs-fMRI). However, the dopaminergic involvement in intrinsic functional connectivity (iFC) and its putative relationship to the development of psychotic spectrum disorders remains partly unclear - in particular at the low-end of the psychosis continuum. Therefore, the investigators examined dopamine-induced changes in striatal iFC and their modulation by psychometrically assessed schizotypy. The randomized, double-blind placebo-controlled study design included 54 healthy, right-handed male participants. Each participant was assessed with the Schizotypal Personality Questionnaire (SPQ) and underwent 10 min of rs-fMRI scanning. Participants then received either a placebo or 200 mg of L-DOPA, a dopamine precursor. The investigators analyzed iFC of six striatal seeds that are known to evoke modulation of dopamine-related networks.
The investigators hypothesized that, within the L-DOPA treatment group, the striatal iFC would be disrupted due to increased availability of dopamine. The investigators further hypothesized that individuals with high schizotypal scores would show a disruption of striatal connectivity, as has been reported with schizophrenia. In addition, the investigators hypothesized that the L-DOPA-dependent change in striatal iFC would interact with the severity of positive symptoms, as has been found in previous studies in non-clinical psychosis. The investigators anticipated this symptom-dependent change, especially in the ventral striatal regions, because these are thought to modulate cortico-striatal loops associated with cognition and emotion.
49 studies on the registry are indexed under Schizotypal Personality Disorder; 12 are open to participants now.
This study's enrollment of 65 is above the median of 54 across 41 interventional studies indexed under Schizotypal Personality Disorder.
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Exclusion Criteria:
A single dose of a cachet filled with 200 mg levodopa/50 mg benserazide
Drug: 200 mg levodopa/50 mg benserazide
A single dose of a cachet filled with Dextrose
Drug: Dextrose
Drug pages: Levodopa · Benserazide
Also known as: Madopar DR
Also known as: Placebo
intrinsic functional connectivity
Dopamine dependent intrinsic functional connectivity as measured by resting-state functional magnetic resonance imaging
Time frame: 2 hours
Schizotypy
Schizotypy scores assessed by the Schizotypal Personality Questionnaire (SPQ): * n of items 74 (min. score = 0 ; max. score = 74): higher score implies higher level of schizotypy * Subscales: * Cognitive Perceptual (min. score = 0 ; max. score = 33) * Interpersonal (min. score = 0 ; max. score = 25) * Disorganized (min. score = 0 ; max. score = 16)
Time frame: 15 min
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2014 to primary completion in Aug 2015, 14 months.
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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Levodopa · Benserazide
Schizotypal Personality Disorder →