Endocrine and Emotional Effects of Lisdexamfetamine and d-Amphetamine. (LisDex)

December 10, 2018 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Basel Stadt
      • Basel, Basel Stadt, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate
Experimental: 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.
Drug: 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.
Other Names:
  • Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate
Experimental: 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.
Drug: 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.
Other Names:
  • Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of lisdexamphetamine and d-Amphetamine on emotion recognition and empathy
Time Frame: 1h
Assessment of emotion recognition and empathy using different Computer Tasks.
1h

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics
Time Frame: 13h
Collection of blood samples for measurement of plasma concentrations
13h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Matthias E Liechti, MD, MAS, University Hospital, Basel, Switzerland
  • Study Chair: Alex Odermatt, Dr., University of Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

December 10, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKNZ 2015-00015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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