NCT00330226 - 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)

Angst F, Stassen HH, Clayton PJ, Angst J
Mortality of patients with mood disorders: follow-up over 34-38 years. J Affect Disord. 2002 Apr;68(2-3):167-81.
Dunner DL
Safety and tolerability of emerging pharmacological treatments for bipolar disorder. Bipolar Disord. 2005 Aug;7(4):307-25. Review.
Kane JM
Treatment of schizophrenia. Schizophr Bull. 1987;13(1):133-56.
McGlashan TH
Early detection and intervention in schizophrenia: research. Schizophr Bull. 1996;22(2):327-45. Review.
Melkersson K, Dahl ML
Adverse metabolic effects associated with atypical antipsychotics: literature review and clinical implications. Drugs. 2004;64(7):701-23. Review.
Swann AC
Long-term treatment in bipolar disorder. J Clin Psychiatry. 2005;66 Suppl 1:7-12. Review.

Naturalistic Prospective Follow-Up of Patients With Schizophrenia or Bipolar Disorders Receiving Atypical Antipsychotics and/or Mood Stabilizers

Clinical trial NCT00330226 - References