NCT00253162 - 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)

Smulevich AB, Khanna S, Eerdekens M, Karcher K, Kramer M, Grossman F
Acute and continuation risperidone monotherapy in bipolar mania: a 3-week placebo-controlled trial followed by a 9-week double-blind trial of risperidone and haloperidol. Eur Neuropsych

The Efficacy And Safety Of Flexible Dose Ranges Of Risperidone Versus Placebo Or Haloperidol In The Treatment Of Manic Episodes Associated With Bipolar I Disorder.

Details for clinical trial NCT00253162

Clinical trial NCT00253162 - References