depression unipolar depressive disorder
Conditions
Interventions
5-HTP challenge test
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - A body mass index (BMI) of 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fMRS ratios in absence or presence of a 5-HTP challenge test: a. choline/creatine b. glycine/creatine c. NAAG (N-acetyl-aspartate-glutamate)/ creatine d. NAA/creatine Outocmes: - Effect of the presence of a 5-HTP challenge test on hypothalamic fMRS activation patterns; - Effect of the absence of a 5-HTP challenge test on hypothalamic fMRS activation patterns. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic parameters: a. plasma ACTH b. plasma total and free cortisol c. plasma prolactin d. saliva cortisol Pharmacokinetic parameters: a. plasma 5-HTP | — |
Countries
Netherlands
Outcome results
None listed