A double-blind, randomized, placebo controlled, single oral dose, two way cross-over trial to investigate the effects of an orally administered 5-HTP challenge test on hypothalamic fMRS activation in healthy male volunteers.
- Conditions
- depressionunipolar depressive disorder10027946
- Registration Number
- NL-OMON31533
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 6
- Age of 18-45 years (extremes included);
- Able and willing to sign the Informed Consent Form prior to screening evaluations;
- Able to refrain from use of all (methyl)xanthines (e.g. coffee, tea, cola, chocolate) during each stay at the CHDR clinic;
- Able to refrain from smoking for the duration of every stay at the CHDR clinic;
- Able to refrain from alcohol use from 24 hours prior to and for the duration of every stay at the CHDR clinic;
- Able to refrain from strenuous physical exercise from 48 hours prior to each dosing until dismissal from the CHDR clinic;
- No disturbed day/night rhythm due to e.g. working in night-shifts or traveling over time zones within 3 weeks prior to the first dose;
- Use of no prescribed drug (especially psychotropic drugs) within two weeks preceding the first dose, excluding paracetamol and certain dermatological preparations (as to judgement of research physician);
- Using a current daily average of a maximum of 4 Units alcohol;
- Using a current daily average of a maximum of 4 Units (methyl)xanthines (e.g. coffee, tea, cola, chocolate);
- Smoking a maximum of 5 cigarettes per day;
- No past or present recreational use of methamphetamines, MDMA or *ecstasy*;
- No history of drug sensitivity.
- A body mass index (BMI) of <18 or >28 kg/m2 (extremes included);
- Cardiac pacemaker, implants not approved for ultra-high field MRI, piercing or other metal objects attached to the body that cannot be removed (dental fillings are allowed);
- (History of) claustrophobia;
- (History of) physical illness as determined by history taking, physical and laboratory examinations, ECG and vital signs recordings;
- Clinically significant pulmonary, cardiac, renal, hepatic, neurological (including epilepsy), endocrinological or gastrointestinal disease;
- Past or present clinically significant DSM-IV psychiatric disorder and/or substance abuse disorder, as diagnosed by GP or psychiatrist;
- Parents, children or siblings with a clinically significant psychiatric disease as diagnosed by GP or psychiatrist;
- Use of illicit drugs within two weeks prior to screening;
- Positive drug screen (morphine, benzodiazepines, cocaine, amphetamine, THC, methamphetamines, MDMA) or alcohol screen at screening and/or admission;
- Blood donation within 90 days prior to the first dose;
- Participation in an investigational drug study within 90 days prior to the first dose, or in four studies (or more) in the past year;
- Positive test result on hepatitis B surface antigen or hepatitis C antibodies;
- Positive test result on HIV 1/2 serology.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>fMRS ratios in absence or presence of a 5-HTP challenge test:<br /><br>a. choline/creatine<br /><br>b. glycine/creatine<br /><br>c. NAAG (N-acetyl-aspartate-glutamate)/ creatine<br /><br>d. NAA/creatine<br /><br><br /><br>Outocmes:<br /><br>- Effect of the presence of a 5-HTP challenge test on hypothalamic fMRS<br /><br>activation patterns;<br /><br>- Effect of the absence of a 5-HTP challenge test on hypothalamic fMRS<br /><br>activation patterns.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacodynamic parameters:<br /><br>a. plasma ACTH<br /><br>b. plasma total and free cortisol<br /><br>c. plasma prolactin<br /><br>d. saliva cortisol<br /><br><br /><br>Pharmacokinetic parameters:<br /><br>a. plasma 5-HTP</p><br>