Enhanced tolerability of the 5-hydroxytryptophane challenge test combined with granisetron

J Psychopharmacol. 2010 Jan;24(1):65-72. doi: 10.1177/0269881108094299. Epub 2008 Aug 21.

Abstract

A recently developed oral serotonergic challenge test consisting of 5-Hydroxytryptophane (5-HTP, 200 mg) combined with carbidopa (CBD, 100 mg + 50 mg) exhibited dose-related neuroendocrine responsiveness and predictable pharmacokinetics. However, its applicability is limited by nausea and vomiting. A randomized, double-blind, placebo-controlled, four-way crossover trial was performed in 12 healthy male volunteers. The 5-HTP/CBD-challenge was combined with two oral anti-emetics (granisetron, 2 mg or domperidone, 10 mg) to investigate its reliability when side-effects are suppressed. The neuroendocrine response (serum cortisol and prolactin), the side-effect profile [Visual Analogue Scale Nausea (VAS)] and vomiting subjects per treatment were the main outcome measures. Compared to 5-HTP/CBD/placebo, 5-HTP/CBD/ granisetron had no impact on cortisol [% change with 95% confidence interval: -7.1% (18.9; 6.5)] or prolactin levels [-9.6% (-25.1; 9.1)]; 5-HTP/CBD/domperidone increased cortisol [+13.0% (-4.2; 33.4)], and increased prolactin extensively [+336.8% (245.7; 451.9)]. Compared to placebo, VAS Nausea increased non-significantly with granisetron [+7.6 mm (-1.3; 16.5)], as opposed to domperidone [+16.2 mm (7.2; 25.2)] and 5-HTP/CBD/placebo [+14.7 mm (5.5; 23.8)]. No subjects vomited with granisetron, compared to two subjects treated with 5-HTP/CBD/placebo and five subjects with domperidone. Compared with 5-HTP/CBD/placebo, granisetron addition decreased C(max) of 5-HTP statistically significantly different (from 1483 to 1272 ng/ml) without influencing AUC(0- infinity). Addition of granisetron to the combined 5-HTP/CBD challenge suppresses nausea and vomiting without influencing the neuroendocrine response or pharmacokinetics, enhancing its clinical applicability in future psychiatric research and drug development.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • 5-Hydroxytryptophan / administration & dosage
  • 5-Hydroxytryptophan / adverse effects*
  • 5-Hydroxytryptophan / pharmacology
  • Adolescent
  • Adult
  • Antidepressive Agents, Second-Generation / administration & dosage
  • Antidepressive Agents, Second-Generation / adverse effects
  • Antidepressive Agents, Second-Generation / pharmacology
  • Antiemetics / pharmacology
  • Area Under Curve
  • Carbidopa / administration & dosage
  • Carbidopa / adverse effects*
  • Carbidopa / pharmacology
  • Cross-Over Studies
  • Domperidone / pharmacology*
  • Dopamine Agents / administration & dosage
  • Dopamine Agents / adverse effects
  • Dopamine Agents / pharmacology
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Interactions
  • Granisetron / pharmacology*
  • Humans
  • Hydrocortisone / blood
  • Male
  • Nausea / chemically induced
  • Nausea / prevention & control
  • Prolactin / blood
  • Vomiting / chemically induced
  • Vomiting / prevention & control
  • Young Adult

Substances

  • Antidepressive Agents, Second-Generation
  • Antiemetics
  • Dopamine Agents
  • Domperidone
  • Prolactin
  • 5-Hydroxytryptophan
  • Carbidopa
  • Hydrocortisone
  • Granisetron