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Completed

NCT Number: NCT02668926

Endocrine and Emotional Effects of Lisdexamfetamine and d-Amphetamine.

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

healthy subjects aged 18-45 years

Exclusion criteria

  • Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG.
  • Current or previous psychotic or major affective disorder
  • Psychotic or major affective disorder in first-degree relatives
  • Prior illicit drug use (cannabis) more than 5 times or any time within the previous 2 months.
  • Pregnant or nursing women.
  • Participation in another clinical trial (currently or within the last 30 days)
  • Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc.)
  • Tobacco smoking (>10 cigarettes/day)

Treatment and study plan

Lisdexamfetamine, d-amphetamine, Placebo

Drug

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.

Other names: Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate

d-amphetamine, Placebo, Lisdexamfetamine

Drug

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.

Other names: Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate

Placebo, Lisdexamfetamine, d-amphetamine

Drug

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.

Other names: Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate

Primary outcomes

  1. Effects of lisdexamphetamine and d-Amphetamine on circulating steroidal hormones

    Time frame: 13 hours

    Measurement of different circulating hormones before and after drug

  2. Subjective effects of lisdexamphetamine and d-amphetamine

    Time frame: 13 hours

    Assessment of subjective effects using visual analog scales

Secondary outcomes

  1. Effects of lisdexamphetamine and d-Amphetamine on emotion recognition and empathy

    Time frame: 1h

    Assessment of emotion recognition and empathy using different Computer Tasks.

Other outcomes

  1. Pharmacokinetics

    Time frame: 13h

    Collection of blood samples for measurement of plasma concentrations

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: LisDex

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 29, 2016
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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