Clinical trial NCT00150527: Specific Effects of Escitalopram on Neuroendocrine Response
Official title: Specific Effects of Escitalopram on Neuroendocrine Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: antidepressive agents
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2005-09-08
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal healthy people

Brief summary: Citalopram, a selective serotonin reuptake inhibitor (SSRI), is used as a neuroendocrine probe in human subjects to assess serotonin (5-hydroxytryptamine; 5-HT) function as reflected in prolactin and plasma cortisol release. Citalopram is a racemic mixture of equal parts of the S(+) and R(-) enantiomers. The S(+) form ("escitalopram") has been identified as being the active isomer and inhibitor of serotonin reuptake and consequently antidepressant activity is associated almost exclusively with the S-enantiomer. Escitalopram has been shown to be approximately twice as potent as citalopram at the primary, high-affinity binding site on the human serotonin transporter. Interestingly, investigations have suggested an antagonistic interaction of the R- and S-enantiomer at an allosteric binding site on the serotonin transporter. This antagonism has been shown in animal studies where the addition of R-citalopram to escitalopram treatments significantly counteracts the antidepressant and anti-anxiolytic effects of escitalopram. From these clinical and experimental data, the researchers can anticipate that escitalopram would increase cortisol and prolactin in the neuroendocrine challenge paradigm more effectively than citalopram.

Detailed description: See above.

Eligibility criteria: Inclusion Criteria:

* The age range will be restricted to between 18 and 59 years of age.
* Subjects must be fit and have no history of significant illness.
* Subjects must have no risk factors for HIV or viral hepatitis.
* Subjects must be non-smokers, free of medication, and consume alcoholic and caffeinated beverages in moderation.
* Subjects must also be in good psychological health with no history of psychiatric illness.

Exclusion Criteria:

* Personal history of psychiatric illness, habitual smoking, illicit or prescription drug use, high intake of alcohol (\>10 drinks/week) or caffeine (\>500 mg caffeine/day), shift work, pregnancy, personal or familial history of seizures, significant medical illness or treatment in the last six months, significant physical or laboratory abnormalities, or current use of a weight loss diet.
* Women entering the study must be on a reliable form of birth control, i.e., tubal ligation, hysterectomy, oral contraceptives, abstinence, or vasectomy in partner.

Primary outcomes:
measure: The effect of the drugs on serum cortisol and ACTH following a single dose of each drug.
timeFrame: 4hrs
Secondary outcomes:
measure: Side effects following a single dose of the drug
timeFrame: 4hrs
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Providence Centre, Mental Health Services
state: Ontario
Study officials:
affiliation: Queen's University
name: Nicholas J Delva, MD
role: PRINCIPAL_INVESTIGATOR
References: