Bipolar II Disorder
Conditions
Brief 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.
Detailed description
This study will extend the understanding of risk factors for drug or alcohol misuse, or other reward-related behaviors. The investigators previously showed that individuals who report occasional feelings of high energy and excitability experience less effect from a single dose of alcohol, compared to people who have not experienced these effects. Now the investigators wish to determine if this dampened response also occurs with other rewards, namely feelings of wellbeing after a dose of amphetamine, or liking of a sweet solution. Individuals who exhibit the BPP (i.e., periods of excitability) also are more likely to develop alcohol problems, substance misuse, and weight gain and obesity. Therefore, the investigators will test the working hypothesis that young adults who report having these experiences, based on a questionnaire measure (i.e., BPP individuals) will show dampened subjective responses to both single oral doses of amphetamine or sweet palatable tastes. The investigators will also obtain objective measures (e.g. Respiratory Sinus Arrhythmia and heart rate) to amphetamine and sweet taste, to establish whether the dampened subjective response extends to physiological indices as well. This study will extend the previous literature regarding the blunted effects of alcohol in BPP individuals and will suggest possible mechanisms that promote broader addictive behaviors in individuals with mood disturbance. Importantly, the investigators are proposing to test individuals at a relatively young age, 18-19 years. This is important to identify a risk factor, that is thought to pre-date use of drugs. In older participants, it would be difficult to separate the role of the pre-existing trait from the effect of habitual drug or alcohol use that escalates markedly after age 20.
Interventions
DRUGPlacebo oral capsule
Placebo oral capsule
DRUGd-amphetamine 10 mg oral capsule
d-amphetamine 10 mg oral capsule
DRUGd-amphetamine 20 mg oral capsule
d-amphetamine 20 mg oral capsule
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Study will track participants in two assigned groups (participants that exhibit either High or Low Bipolar II/Hypomanic phenotypes)
Eligibility
Sex/Gender
ALL
Age
18 Years to 19 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | End of study (Baseline - time 0 and approximately 4 weeks later) | Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective stimulant profile. The Dug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: Feel Drug, Feel High, Like Drug, and Want More. All sub-scales are scored on a visual analogue scale (Scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Arm Participant will receive placebo oral capsule during this four hour session.
Placebo oral capsule: Placebo oral capsule | 31 |
| Amphetamine 10 mg Arm Participant will receive d-amphetamine 10 mg oral capsule during this four hour session.
d-amphetamine 10 mg oral capsule: d-amphetamine 10 mg oral capsule | 31 |
| Amphetamine 20 mg Arm Participant will receive d-amphetamine 20 mg oral capsule during this four hour session.
d-amphetamine 20 mg oral capsule: d-amphetamine 20 mg oral capsule | 31 |
| Total | 93 |
Baseline characteristics
| Characteristic | Placebo Arm | Amphetamine 10 mg Arm | Amphetamine 20 mg Arm | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 31 Participants | 31 Participants | 93 Participants |
| Education - High School Education | 31 Participants | 31 Participants | 31 Participants | 93 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 4 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 24 Participants | 24 Participants | 72 Participants |
| Region of Enrollment United States | 31 participants | 31 participants | 31 participants | 93 participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 13 Participants | 39 Participants |
| Sex: Female, Male Male | 18 Participants | 18 Participants | 18 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 31 | 0 / 31 |
| other Total, other adverse events | 0 / 31 | 0 / 31 | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 | 0 / 31 |
Outcome results
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).
Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective stimulant profile. The Dug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: Feel Drug, Feel High, Like Drug, and Want More. All sub-scales are scored on a visual analogue scale (Scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.
Time frame: End of study (Baseline - time 0 and approximately 4 weeks later)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Arm | 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). | High | 17.50 score on a scale | Standard Error 5.5 |
| Placebo Arm | 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). | Dislike | 19.00 score on a scale | Standard Error 5.96 |
| Placebo Arm | 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). | Feel | 18.88 score on a scale | Standard Error 8.84 |
| Placebo Arm | 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). | Like | 37.44 score on a scale | Standard Error 7.64 |
| Placebo Arm | 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). | More | 29.19 score on a scale | Standard Error 7.56 |
| Amphetamine 10 mg Arm | 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). | Dislike | 27.19 score on a scale | Standard Error 6.47 |
| Amphetamine 10 mg Arm | 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). | Feel | 35.25 score on a scale | Standard Error 4.46 |
| Amphetamine 10 mg Arm | 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). | Like | 50.69 score on a scale | Standard Error 7.82 |
| Amphetamine 10 mg Arm | 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). | High | 24.88 score on a scale | Standard Error 5.48 |
| Amphetamine 10 mg Arm | 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). | More | 45.38 score on a scale | Standard Error 7.66 |
| Amphetamine 20 mg Arm | 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). | More | 52.44 score on a scale | Standard Error 8.4 |
| Amphetamine 20 mg Arm | 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). | High | 32.69 score on a scale | Standard Error 8.68 |
| Amphetamine 20 mg Arm | 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). | Feel | 45.75 score on a scale | Standard Error 8.23 |
| Amphetamine 20 mg Arm | 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). | Dislike | 16.25 score on a scale | Standard Error 5.15 |
| Amphetamine 20 mg Arm | 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). | Like | 52.81 score on a scale | Standard Error 8.96 |