Endocrine and Emotional Effects of Lisdexamfetamine and d-Amphetamine.
This trial has been completed.
|Treatments||lisdexamfetamine, d-amphetamine, placebo, d-amphetamine, placebo, lisdexamfetamine, placebo, lisdexamfetamine, d-amphetamine|
|Sponsor||University Hospital, Basel, Switzerland|
|Start date||May 2016|
|End date||June 2016|
|Trial size||24 participants|
|Trial identifier||NCT02668926, EKNZ 2015-00015|
The study will compare the acute emotional and endocrine effects of equivalent doses of lisdexamfetamine and amphetamine in healthy subjects. In addition the pharmacokinetics and effects of the amphetamines on aspects of social cognition are investigated.
|Intervention model||crossover assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
|Primary purpose||basic science|
Effects of lisdexamphetamine and d-Amphetamine on circulating steroidal hormones
time frame: 13 hours
Subjective effects of lisdexamphetamine and d-amphetamine
time frame: 13 hours
Effects of lisdexamphetamine and d-Amphetamine on emotion recognition and empathy
time frame: 1h
Male or female participants from 18 years up to 45 years old.
Inclusion Criteria: healthy subjects aged 18-45 years Exclusion Criteria: 1. Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. 2. Current or previous psychotic or major affective disorder 3. Psychotic or major affective disorder in first-degree relatives 4. Prior illicit drug use (cannabis) more than 5 times or any time within the previous 2 months. 5. Pregnant or nursing women. 6. Participation in another clinical trial (currently or within the last 30 days) 7. Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc.) 8. Tobacco smoking (>10 cigarettes/day)
|Official title||Endocrine and Emotional Effects of Lisdexamfetamine and d- Amphetamine: a Placebo-controlled Study in Healthy Subjects (LisDexStudy)|
|Principal investigator||Matthias E Liechti, MD, MAS|
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