NCT03863691 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Billman GE, Huikuri HV, Sacha J, Trimmel K
An introduction to heart rate variability: methodological considerations and clinical applications. Front Physiol. 2015 Feb 25;6:55. doi: 10.3389/fphys.2015.00055. eCollection 2015.
Horan WP, Reddy LF, Barch DM, Buchanan RW, Dunayevich E, Gold JM, Marder SR, Wynn JK, Young JW, Green MF
Effort-Based Decision-Making Paradigms for Clinical Trials in Schizophrenia: Part 2-External Validity and Correlates. Schizophr Bull. 2015 Sep;41(5):1055-65. doi: 10.1093/schbul/sbv090. Epub 2015 Jul 23.
Reddy LF, Horan WP, Barch DM, Buchanan RW, Dunayevich E, Gold JM, Lyons N, Marder SR, Treadway MT, Wynn JK, Young JW, Green MF
Effort-Based Decision-Making Paradigms for Clinical Trials in Schizophrenia: Part 1-Psychometric Characteristics of 5 Paradigms. Schizophr Bull. 2015 Sep;41(5):1045-54. doi: 10.1093/schbul/sbv089. Epub 2015 Jul 3.
Shilton AL, Laycock R, Crewther SG
The Maastricht Acute Stress Test (MAST): Physiological and Subjective Responses in Anticipation, and Post-stress. Front Psychol. 2017 Apr 19;8:567. doi: 10.3389/fpsyg.2017.00567. eCollection 2017.
Strauss GP, Frost KH, Lee BG, Gold JM
THE POSITIVITY OFFSET THEORY OF ANHEDONIA IN SCHIZOPHRENIA. Clin Psychol Sci. 2017 Mar;5(2):226-238. doi: 10.1177/2167702616674989. Epub 2017 Mar 10.

Influence of Partial Blockade of Dopaminergic Neurotransmission Using Amisulpride on Stress Responsivity, Motivated Behavior and Emotional Reactivity in Humans.

Details for clinical trial NCT03863691

Clinical trial NCT03863691 - References