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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02342366 |
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Date of registration:
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14/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Characterization of the Prosocial and Prosexual Effects of GHB
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Scientific title:
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Multimodal Characterization of the Prosocial and Prosexual Effects of GHB Assessing Behavior, fMRI, EEG, and Neuroendocrine Mechanisms |
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Date of first enrolment:
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February 2012 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02342366 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Erich Seifritz, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Zurich |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy male subjects.
Exclusion Criteria:
- Any Axis-I DSM-IV psychiatric disorder, any form of addiction or regular illegal drug
use (lifetime use >5 occasions) with exception of occasional cannabis use, a lifetime
history of GHB use, a neurological disorder or head injury, clinically relevant
medical diseases, a family history of schizophrenia or bipolar disorder, and any use
of prescription drugs.
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Bipolar Disorder
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Depressive Disorder, Major
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Autistic Disorder
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Intervention(s)
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Drug: GHB 20 mg/kg p.o.
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Drug: GHB 35 mg/kg p.o.
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Primary Outcome(s)
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Sexual Arousal
[Time Frame: 14 days]
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Social Cognition and Behavior
[Time Frame: 14 days]
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Secondary Outcome(s)
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Composite measure of Neuroendocrine Parameters
[Time Frame: 14 days]
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fMRI activity
[Time Frame: 14 days]
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electroencephalography (EEG) activity
[Time Frame: 14 days]
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Secondary ID(s)
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PUK-GHB01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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