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

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ClinicalTrials.gov Identifier: NCT02668926
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE January 21, 2016
First Posted Date  ICMJE January 29, 2016
Last Update Posted Date December 11, 2018
Study Start Date  ICMJE May 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2016)
  • Effects of lisdexamphetamine and d-Amphetamine on circulating steroidal hormones [ Time Frame: 13 hours ]
    Measurement of different circulating hormones before and after drug
  • Subjective effects of lisdexamphetamine and d-amphetamine [ Time Frame: 13 hours ]
    Assessment of subjective effects using visual analog scales
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
  • Effects of lisdexamphetamine and d-Amphetamine on circulating steroidal hormones [ Time Frame: 13 hours ]
    Measurement of different circulating hormones before and after drug
  • Subjective effects of lisdexamphetamine and d-amphetamine [ Time Frame: 13 hours ]
    Assessment of subjective effects using visual anaolg scales
Change History Complete list of historical versions of study NCT02668926 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
Effects of lisdexamphetamine and d-Amphetamine on emotion recognition and empathy [ Time Frame: 1h ]
Assessment of emotion recognition and empathy using different Computer Tasks.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 26, 2016)
Pharmacokinetics [ Time Frame: 13h ]
Collection of blood samples for measurement of plasma concentrations
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Endocrine and Emotional Effects of Lisdexamfetamine and d-Amphetamine.
Official Title  ICMJE Endocrine and Emotional Effects of Lisdexamfetamine and d- Amphetamine: a Placebo-controlled Study in Healthy Subjects (LisDexStudy)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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 Name: Lisdexamfetamine=Elvanse, d-amphetamine=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 Name: Lisdexamfetamine=Elvanse, d-amphetamine=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 Name: Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Lisdexamfetamine, d-amphetamine, Placebo
  • 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.
    Intervention: Drug: d-amphetamine, Placebo, Lisdexamfetamine
  • 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.
    Intervention: Drug: Placebo, Lisdexamfetamine, d-amphetamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2016)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02668926
Other Study ID Numbers  ICMJE EKNZ 2015-00015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthias E Liechti, MD, MAS University Hospital, Basel, Switzerland
Study Chair: Alex Odermatt, Dr. University of Basel
PRS Account University Hospital, Basel, Switzerland
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP