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Phase 1 N=93 Randomized Double-blind Basic Science

Differential Responses to Drugs and Sweet Tastes

Bipolar II Disorder

Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ). — 18.88; 35.25; 45.75; 37.44 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Placebo oral capsule (Drug); d-amphetamine 10 mg oral capsule (Drug); d-amphetamine 20 mg oral capsule (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of Chicago
Primary completion
Aug 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ).
18.88; 35.25; 45.75; 37.44; 50.69; 52.81

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.

Eligibility Criteria

Inclusion Criteria

  • Aged 18-19 years old
  • BMI of 19-26
  • Physical/EKG/Medical History/Medications Approved by Physician for d-amphetamine
  • at least High School education
  • Fluent in English

Exclusion Criteria

  • No Current Mood, Anxiety, Eating or Psychotic Disorder
  • No current psychotropic medication
  • No Recent Drug Dependence
  • < 4 alcoholic drinks/day for males; < 3 alcoholic drinks/day for females (monthly average)
  • No weekly (or more frequent) illicit drug use
  • No women who are pregnant, nursing, or planning pregnancy within 3 months (birth control is okay)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03810703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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