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- Registre américain des essais cliniques
- Essai clinique NCT00607568
Atomoxetine Effects in Humans
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This pilot study will examine the effects of a norepinephrine reuptake blocker, atomoxetine, on physiological and subjective responses to physical and psychological models of stress and oral amphetamine in healthy volunteers. The physical stress model will be the cold pressor test (CPT) and the psychological stress will be the paced auditory serial addition task (PASAT).
Our overall hypothesis is that atomoxetine treatment, compared to placebo, will attenuate the physiological and subjective responses to stress and d-amphetamine.
2. Research Design: Double-blind, placebo-controlled, within-groups, outpatient study.
3. Methodology: A total of 18 healthy volunteers will participate in this four-week, within-groups, double-blind, placebo-controlled study. The study has two phases separated by a 4 to 15-day washout period. Subjects will be randomly assigned to receive either 40 mg atomoxetine or placebo. For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. After receiving medication or placebo for three days, subjects will have a 6-hour laboratory session, where responses to physical and psychological stress of a 20 mg/70 kg (20 mg maximum) dose of d-amphetamine will be measured. Several physiological, hormonal, and subjective outcome measures will be obtained during the experimental sessions. Subjects will then have a 4-15 day washout period and will be crossed over to the alternative treatment for Phase II.
4. Findings: Since our last renewal, a total of 16 subjects signed the consent form. Among those, 6 subjects did not return after signing the consent form. An additional 2 subjects were randomized but did not complete the study. One subjects started 3 times was randomized 3 times therefore counted three times in enrollment. Currently still enrolling subjects. (2/7/07)
Have completed this study with 10 subjects, study was published. This study has been entered twice.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- La phase 1
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Female and males age 18 yrs to 45 yrs
- Current history of good health and normal ECG
- not pregnant , nor breast feeding
- using acceptable birth control methods
Exclusion Criteria:
- History of heart disease, hypertension, renal or hepatic diseases, glaucoma,hyperthyroidism,
- Current use of psychotropic medication
- Current dependence on alcohol or on drugs or treatments for drug or alcohol addiction within the past 5 years
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 1
atomoxetine 40mg per day
|
atomoxetine 40mg per day or placebo For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. Subjects will then have a 4-15 day washout period and will be crossed over to the alternative treatment for Phase II. |
Comparateur placebo: 2
second arm is placebo, sugar pill
|
atomoxetine 40mg per day or placebo For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. Subjects will then have a 4-15 day washout period and will be crossed over to the alternative treatment for Phase II. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Atomoxetine treatment, compared to placebo, will attenuate the physiological and subjective responses to stress and d-amphetamine
Délai: one year
|
one year
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Mehmet Sofuoglu, M.D., Ph.D., Yale University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MIRECC HIC 0605001441
- DPMC (Autre identifiant: NIDA)
- K02DA021304 (Subvention/contrat des NIH des États-Unis)
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