Endocrine and Emotional Effects of Lisdexamfetamine and d-Amphetamine.

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: d-amphetamine, Placebo, Lisdexamfetamine; Drug: Lisdexamfetamine, d-amphetamine, Placebo; Drug: Placebo, Lisdexamfetamine, d-amphetamine

• Registration Number: NCT02668926
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Study Start: 2016-05
• Primary Completion: 2016-06
• Study Completion: 2016-12
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-10
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
d-amphetamine, Placebo, Lisdexamfetamine	d-amphetamine, Placebo, Lisdexamfetamine	Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 3 arms with three treatment conditions in the same subject. The three treatment conditions are placebo, lisdexamfetamine, and d-Amphetamine sulfate.
Lisdexamfetamine, d-amphetamine, Placebo	Lisdexamfetamine, d-amphetamine, Placebo	Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 3 arms with three treatment conditions in the same subject. The three treatment conditions are placebo, lisdexamfetamine, and d-Amphetamine sulfate.
Placebo, Lisdexamfetamine, d-amphetamine	Placebo, Lisdexamfetamine, d-amphetamine	Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 3 arms with three treatment conditions in the same subject. The three treatment conditions are placebo, lisdexamfetamine, and d-Amphetamine sulfate.

Primary Outcome Measures

Name	Time	Method
Effects of lisdexamphetamine and d-Amphetamine on circulating steroidal hormones	13 hours	Measurement of different circulating hormones before and after drug
Subjective effects of lisdexamphetamine and d-amphetamine	13 hours	Assessment of subjective effects using visual analog scales

Secondary Outcome Measures

Name	Time	Method
Effects of lisdexamphetamine and d-Amphetamine on emotion recognition and empathy	1h	Assessment of emotion recognition and empathy using different Computer Tasks.

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Basel Stadt, Switzerland