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CompletedNCT03333369Updated Nov 6, 2017

Exceptional Experiences (EE), Salience & Dopaminergic Neurotransmission

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

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled May 2014, registered Oct 2017).

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Phase
Early Phase 1
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Healthy
  • Schizotypal Personality

Keywords

  • resting-state functional MRI
  • Dopamine
  • functional connectivity
03

In context

Schizotypal Personality Disorder

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.

Browse Schizotypal Personality Disorder studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,051 studies on the registry; 134 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy,
  • Between 20 and 40 years of age,
  • With exceptional experiences or skeptics,
  • Caucasian origin,
  • Normal visual and acoustic accuracy.

Exclusion criteria

Exclusion Criteria:

  • Persons with a personal or first-degree family history of neurological and psychiatric disease, including impaired cognitive abilities,
  • Pregnant or breastfeeding women,
  • Chronic or acute pain,
  • Acute or chronic somatic disease,
  • Women (i.e. only men included),
  • Men over 40 years of age or below 20,
  • left- or mixed-handedness,
  • General MRI exclusion criteria,
  • General Dopamine-Challenge exclusion criteria,
  • Hormonal or herbal therapy,
  • Smoker.
05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
65 participants (actual)

Study arms

  • Active comparator
    Madopar Arm

    A single dose of a cachet filled with 200 mg levodopa/50 mg benserazide

    Drug: 200 mg levodopa/50 mg benserazide

  • Placebo comparator
    Placebo Arm

    A single dose of a cachet filled with Dextrose

    Drug: Dextrose

Interventions

  • Drug200 mg levodopa/50 mg benserazide

    Drug pages: Levodopa · Benserazide

    Also known as: Madopar DR

  • DrugDextrose

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. intrinsic functional connectivity

    Dopamine dependent intrinsic functional connectivity as measured by resting-state functional magnetic resonance imaging

    Time frame: 2 hours

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Collegium Helveticum, ETH & Universität Zürich
    Zürich, 8006 Zürich, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2014 to primary completion in Aug 2015, 14 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 30, 2017
First posted
Nov 6, 2017
StartActual
May 15, 2014
Primary completionActual
Aug 13, 2015
CompletionActual
Aug 13, 2015
Last update
Nov 6, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03333369
Responsible party
Sponsor
First posted
Nov 6, 2017
Start date
May 15, 2014
Primary completion
Aug 13, 2015
Completion
Aug 13, 2015
Last update
Nov 6, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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