Endocrine and Emotional Effects of Lisdexamfetamine and d-Amphetamine.

NCT02668926 | Completed Phase 1 DMC

• 1 other identifier: EKNZ 2015-00015
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Effects of lisdexamphetamine and d-Amphetamine on circulating steroidal hormones

  Measurement of different circulating hormones before and after drug

  13 hours

• Subjective effects of lisdexamphetamine and d-amphetamine

  Assessment of subjective effects using visual analog scales

  13 hours

Secondary Outcomes (1)

• Effects of lisdexamphetamine and d-Amphetamine on emotion recognition and empathy

  1h

Other Outcomes (1)

• Pharmacokinetics

  13h

Study Arms (3)

Lisdexamfetamine, d-amphetamine, Placebo

EXPERIMENTAL

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

d-amphetamine, Placebo, Lisdexamfetamine

EXPERIMENTAL

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

Placebo, Lisdexamfetamine, d-amphetamine

EXPERIMENTAL

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

Interventions

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.

Also known as: Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate

Lisdexamfetamine, d-amphetamine, Placebo

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.

Also known as: Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate

d-amphetamine, Placebo, Lisdexamfetamine

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.

Also known as: Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate

Placebo, Lisdexamfetamine, d-amphetamine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy subjects aged 18-45 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (2)

• Dolder PC, Strajhar P, Vizeli P, Odermatt A, Liechti ME. Acute effects of lisdexamfetamine and D-amphetamine on social cognition and cognitive performance in a placebo-controlled study in healthy subjects. Psychopharmacology (Berl). 2018 May;235(5):1389-1402. doi: 10.1007/s00213-018-4849-0. Epub 2018 Feb 9.

  PMID: 29511807 DERIVED

• Dolder PC, Strajhar P, Vizeli P, Hammann F, Odermatt A, Liechti ME. Pharmacokinetics and Pharmacodynamics of Lisdexamfetamine Compared with D-Amphetamine in Healthy Subjects. Front Pharmacol. 2017 Sep 7;8:617. doi: 10.3389/fphar.2017.00617. eCollection 2017.

  PMID: 28936175 DERIVED

MeSH Terms

Interventions

Lisdexamfetamine Dimesylate; Dextroamphetamine

Intervention Hierarchy (Ancestors)

Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Matthias E Liechti, MD, MAS

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Alex Odermatt, Dr.

  University of Basel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: January 29, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 11, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)