A double-blind, randomized, three-way cross-over trial to develop a pharmacologic challenge with ketamine.

Completed

• Conditions: psychotic disorder; schizophrenia; 10039628

• Registration Number: NL-OMON34124
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Age between 18 and 45 (extremes included)
Body Mass Index (BMI) between 18 and 30 kg/m2 (extremes included)
Mild cannabis users (defined as >= 4 times in last year and <= 1x/week in last year)
Willing to provide informed consent to participate in the study and to comply with all study procedures

Exclusion Criteria

Clinically significant (history of) disease as determined by medical history, physical examination, ECG or routine blood chemistry, hematology or virology tests.
Clinically significant (history of) psychiatric illnesses (including substance abuse) or (history of) psychotic symptoms
Family history of relevant psychiatric disorders (first degree) and/or psychotic disorders (first and second degree)
Smokes more than five cigarettes a day
Positive urine drug screen for recreational drugs (i.e. cocaine, opioids, benzodiazepines, amphetamines, metamphetamines, MDMA or THC)
Positive urine pregnancy test or breastfeeding
Exposure to medication (including St. John's Wort) known to interfere with CYP3A4 metabolism within 14 days prior to dosing
Unable or unwilling to refrain from smoking, heavy physical exercise or the use of alcohol, xanthine, or grapefruit juice 24 hours prior to dosing until discharge.
Blood loss or donation outside the limits of the Dutch blood bank (Sanquin)
Participation in a clinical study within the past three months, or participation within four or more clinical studies in the past twelve months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Positive and negative syndrome scale (PANSS), pre-pulse inhibition (PPI),<br /><br>visual analogue scales (VAS Bowdle and VAS Bond and Lader), eye movements<br /><br>(saccadic and smooth pursuit), pupillometry, body sway and pharmacokinetics<br /><br>(S(+)-ketamine and S(+)-norketamine).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N/A</p><br>