- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01411813
Alprazolam and Eating Behavior in Anorexia Nervosa
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
30 patients with Anorexia Nervosa (hospitalized at NYSPI 4-Center for acute weight restoration treatment) will be recruited to participate in this experiment. All subjects will be screened on admission and provide informed consent prior to participation. At the time of study procedures, participants will be medically stable and weigh ≥ 80% IBW. This minimum weight has been identified for patient safety given the test meal procedures. Subjects will participate in a total of two meal sessions on the BSU. Medical clearance will be determined by 4-Center clinical staff prior to the meal sessions. Study participation will not prolong nor interfere with the patient's treatment.
The first test meal will occur after the patient has reached 80% IBW. The second test meal will occur within a week of the first. The procedures are identical for the two test sessions, and were based on those described by Sysko and colleagues (9). On the morning of the test meal, participants will be provided a standardized breakfast of ~300 kcal. They will not consume any additional food or liquid, other than water, prior to the test meal session approximately 4 hours later. Study medication will be administered at 10:00 am.
Test meals will be conducted on the Biological Studies Unit (BSU) at NYSPI. Participants will be escorted to and from the BSU by research staff. Participants will complete questionnaires prior to receiving medication, prior to each test meal, and after the test meal is complete (see Table). Participants will be presented with an 83 fluid ounce covered opaque container with a straw on a table. Inside the container will be approximately 1500 grams (approximately 1560 kcal) of strawberry yogurt shake. Patients will be informed that the meal consists of a strawberry yogurt shake, but will not be informed as to the amount provided in the container. Instructions before each test meal will inform patients that they should eat as much of the shake as they would like, and that the meal would serve as their lunch for the day. The participant will be alone in the room. For compliance and safety, patients will be observed through a closed circuit video monitor during the meal. The patient will be instructed to signal completion of the meal by ringing a bell. During the course of the meal, patients will be asked to rate anxiety periodically. After the test meal is complete, a staff member will debrief the participant and address any questions or concerns.
Medication Administration: Participants will receive active medication (alprazolam 0.75 mg) on one test day and placebo on the other, in random order. Dose was selected based on the findings of Evans et al (8), who demonstrated statistically significant increases in caloric intake with doses of alprazolam 0.5 mg and 0.75 mg. Medication will be administered 2 hours prior to the test meal, as this is the timing of estimated peak plasma concentration (8).
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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New York
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New York, New York, Stati Uniti, 10032
- New York State Psychiatric Institute
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- DSM-IV-TR™ diagnosis of anorexia nervosa (restricting or binge-purge subtype), with or without amenorrhea at the time of inpatient admission.
- Older than 18
- No acute medical condition
- Participation in inpatient treatment
- Subjects must have signed informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion Criteria:
- Psychotic or bipolar I disorder
- Substance abuse or dependence in the last 6 months
- Current Axis I disorder requiring psychotropic medication (subjects taking a stable dose of psychiatric medications will be allowed.)
- Active suicidal intent.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Alprazolam
Patients receiving Alprazolam.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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change in caloric Intake
Lasso di tempo: Change in caloric intake between test meals
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Assessment of caloric intake after taking alprazolam or placebo.
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Change in caloric intake between test meals
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Joanna Steinglass, MD, New York State Psychiatric Institute
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- #6267
- 5R01MH082736 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .