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NCT02668926 Clinical Trial

Endocrine and Emotional Effects of Lisdexamfetamine and d-Amphetamine.

Healthy Clinical Trial

— LisDex  

Official title:
Endocrine and Emotional Effects of Lisdexamfetamine and d- Amphetamine: a Placebo-controlled Study in Healthy Subjects (LisDexStudy)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02668926
Other study ID # EKNZ 2015-00015
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 2016
Est. completion date December 2016

Study information
Verified date December 2018
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date December 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lisdexamfetamine, d-amphetamine, Placebo
Elvanse (Lisdexamfetamine): 100mg p.o, single dose; d-Amphetamine: 40.3mg p.o, single dose; Placebo: Capsules containing mannitol looking identical to lisdexamphetamine and d-Amphetamine.
• d-amphetamine, Placebo, Lisdexamfetamine
Elvanse (Lisdexamfetamine): 100mg p.o, single dose; d-Amphetamine: 40.3mg p.o, single dose; Placebo: Capsules containing mannitol looking identical to lisdexamphetamine and d-Amphetamine.
• Placebo, Lisdexamfetamine, d-amphetamine
Elvanse (Lisdexamfetamine): 100mg p.o, single dose; d-Amphetamine: 40.3mg p.o, single dose; Placebo: Capsules containing mannitol looking identical to lisdexamphetamine and d-Amphetamine.

Locations
Country Name City State
Switzerland University Hospital Basel Basel Basel Stadt

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Other Pharmacokinetics Collection of blood samples for measurement of plasma concentrations 13h
Primary Effects of lisdexamphetamine and d-Amphetamine on circulating steroidal hormones Measurement of different circulating hormones before and after drug 13 hours
Primary Subjective effects of lisdexamphetamine and d-amphetamine Assessment of subjective effects using visual analog scales 13 hours
Secondary Effects of lisdexamphetamine and d-Amphetamine on emotion recognition and empathy Assessment of emotion recognition and empathy using different Computer Tasks. 1h
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