T P Laughren
Affiliation: Food and Drug Administration
- The scientific and ethical basis for placebo-controlled trials in depression and schizophrenia: an FDA perspectiveT P Laughren
Psychiatric Drug Products Group, Division of Neuropharmacological Drug Products HFD 120, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, USA
Eur Psychiatry 16:418-23. 2001..Preliminary data on suicides in placebo-controlled depression and schizophrenia trials will be presented to argue for the ethical acceptability of the conduct of placebo-controlled trials in these two conditions...
- Food and Drug Administration perspective on negative symptoms in schizophrenia as a target for a drug treatment claimThomas Laughren
Food and Drug Administration, DNDP, HFD 120, 5600 Fishers Lane, Rockville, MD 20853, USA
Schizophr Bull 32:220-2. 2006....
- Suicidality in pediatric patients treated with antidepressant drugsTarek A Hammad
Division of Neuropharmacological Drug Products, HFD 120, 5600 Fishers Lane, Rockville, MD 20857, USA
Arch Gen Psychiatry 63:332-9. 2006..There has been concern that widely used antidepressant agents might be associated with an increased risk of suicidal ideation and behavior (suicidality) in pediatric patients...
- A summary of the FDA-NIMH-MATRICS workshop on clinical trial design for neurocognitive drugs for schizophreniaRobert W Buchanan
Maryland Psychiatric Research Center, P O Box 21247, Baltimore, MD 21228, USA
Schizophr Bull 31:5-19. 2005....
- Assessment of community functioning in people with schizophrenia and other severe mental illnesses: a white paper based on an NIMH-sponsored workshopAlan S Bellack
University of Maryland School of Medicine, 737 West Lombard Street, Suite 551, Baltimore, MD 21201, USA
Schizophr Bull 33:805-22. 2007..quot; This criterion is problematic because different observers and constituencies often have different opinions about what types of change are clinically important and how much change is significant...
- Wayne Fenton: impact on food and drug administrationThomas Laughren
Schizophr Bull 33:1153. 2007
- Developing strategies for psychopharmacological studies in preschool childrenLaurence L Greenhill
New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA
J Am Acad Child Adolesc Psychiatry 42:406-14. 2003..To identify the obstacles and special challenges-ethical, practical, scientific, and regulatory-faced by investigators who attempt to conduct psychopharmacological studies in preschoolers...
- Conventional vs. atypical antipsychotic medicationsMarc Stone
N Engl J Med 354:972-4; author reply 972-4. 2006