Craighead, W E., Miklowitz, D.J., Vajk, F.C. and Frank, E. Psychosocial treatments for bipolar disorder. In: A Guide to Treatments that Work, edited by P.E. Nathan and J.M. Gorman, Oxford University Press, New York, NY, 240-248, 1997 .
Frank E, Swartz HA, Kupfer DJ Interpersonal and social rhythm therapy: managing the chaos of bipolar disorder. Biol Psychiatry. 2000 Sep 15;48(6):593-604. Review.
Hlastala, S A. and Frank, E. Biology versus environment: Stessors in the pathophysiology of bipolar disorder. In: Bipolar Disorders: Basic Mechanisms and Therapeutic Implications. J. Soares and S. Gershon (Eds.), Marcel Dekker, Inc., New York, NY, 353-372
Kupfer, D J., Frank, E., Grochocinski, V.J., Luther, J.F., Houck, P.R., Swartz, H.A. and Mallinger, A.G. Stabilization in the treatment of mania, depression and mixed states. Acta Neuropsychiatrica, 12:110-114, 2000.
Lenze, E J., Miller, M.D., Dew, M.A., Martine, L.M., Begley, A.E., Schulz, R., Frank, E. and Reynolds, C.F., III. Health measures as outcomes and predictors of response during acute treatment for late-life depression. International Journal of Geriatric Ps
Miklowitz DJ, Frank E, George EL New psychosocial treatments for the outpatient management of bipolar disorder. Psychopharmacol Bull. 1996;32(4):613-21.
Miklowitz, D J. and Frank, E. New psychotherapies for bipolar disorder. In: Bipolar Disorder: Clinical Course and Outcome, edited by J. Goldberg and M. Harrow, American Psychiatric Press, Washington, D.C.,57-84, 1999.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
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.
