NCT00794040 - 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)

Amsterdam JD, Shults J
Comparison of fluoxetine, olanzapine, and combined fluoxetine plus olanzapine initial therapy of bipolar type I and type II major depression--lack of manic induction. J Affect Disord. 2005 Jul;87(1):121-30.
Baumer FM, Howe M, Gallelli K, Simeonova DI, Hallmayer J, Chang KD
A pilot study of antidepressant-induced mania in pediatric bipolar disorder: Characteristics, risk factors, and the serotonin transporter gene. Biol Psychiatry. 2006 Nov 1;60(9):1005-12. Epub 2006 Aug 30.
Binks CA, Fenton M, McCarthy L, Lee T, Adams CE, Duggan C
Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD005653. Review. Update in: Cochrane Database Syst Rev. 2010;(6):CD005653.

A Controlled Trial of Citalopram Added to Methylphenidate in Youth With Severe Mood Dysregulation

Clinical trial NCT00794040 - References