CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 93 enrolled
Drug / intervention
Placebo oral capsule +2 moredrug
Likely dose
d-amphetamine 10 mg oral capsulefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03810703
NCT03810703Phase 1Completed

Hypomania, Amphetamine, and Preferences for Sweets

University of Chicago·interventional·Posted Jan 22, 2019·Updated Feb 22, 2023

In Brief

A Phase 1 clinical trial evaluating Placebo oral capsule, d-amphetamine 10 mg oral capsule, and 1 other intervention for Bipolar II Disorder. Completed, enrolled 93 participants across 2 sites.

Detailed Summary

Young adults who exhibit "bipolar phenotype" (BPP), defined as occasional episodes of mood elevation and heightened activity, are at risk for several psychiatric disorders, including problem use of drugs and alcohol. Mood elevation has been linked to higher alcohol consumption and alcohol use disorders. Individuals with BPP show elevated lifetime prevalence of alcohol use disorders (between 39%-61%), figures that exceed those reported in both major depression and schizophrenia. Recently, the investigators demonstrated in a controlled laboratory study that individuals with BPP (but not meeting criteria for full Bipolar I Disorder), report dampened responses to a single dose of alcohol, compared to placebo. In the current study, the investigators seek to extend these findings to determine if young adults reporting BPP, based on a questionnaire, will exhibit reduced responses to other rewarding stimuli, such as d-amphetamine and sweet tastes. The investigators hypothesize that the BPP individuals will exhibit dampened subjective responses to stimulant and sweet taste rewards compared to healthy controls.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 22, 2019
Enrollment StartFeb 9, 2017
Primary CompletionAug 9, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.4 years ago

Interventions

Placebo oral capsuledrug

Placebo oral capsule

d-amphetamine 10 mg oral capsuledrug

d-amphetamine 10 mg oral capsule

d-amphetamine 20 mg oral capsuledrug

d-amphetamine 20 mg oral capsule