NCT03397134 - 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)

Davidson M, Saoud J, Staner C, Noel N, Werner S, Luthringer E, Walling D, Weiser M, Harvey PD, Strauss GP, Luthringer R
Efficacy and Safety of Roluperidone for the Treatment of Negative Symptoms of Schizophrenia. Schizophr Bull. 2022 May 7;48(3):609-619.

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Monotherapy, 12-Week Study to Evaluate the Efficacy and Safety of 2 Fixed Doses of MIN-101 in Adult Patients With Negative Symptoms of Schizophrenia, Followed by a 40-Week Open-Label Extension

Details for clinical trial NCT03397134

Clinical trial NCT03397134 - References