Endocrine and Emotional Effects of Lisdexamfetamine and d-Amphetamine.
NCT ID: NCT02668926
Last Updated: 2018-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2016-05-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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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.
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
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.
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
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
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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)
18 Years
45 Years
ALL
Yes
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Matthias E Liechti, MD, MAS
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Alex Odermatt, Dr.
Role: STUDY_CHAIR
University of Basel
Locations
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University Hospital Basel
Basel, Canton of Basel-City, Switzerland
Countries
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References
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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.
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.
Other Identifiers
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EKNZ 2015-00015
Identifier Type: -
Identifier Source: org_study_id