Frequency of Positive Studies Among Fixed and Flexible Dose Antidepressant Clinical Trials: An Analysis of the Food and Drug Administraton Summary Basis of Approval Reports

Author:

Khan Arif,Khan Shirin R,Walens Gary,Kolts Russell,Giller Earl L

Publisher

Springer Science and Business Media LLC

Subject

Psychiatry and Mental health,Pharmacology

Reference9 articles.

1. Benkert O, Szegedi A, Wetzel H (1996). Minimum effective dose for the antidepressants—an obligatory requirement for antidepressant drug evaluation? Int Clin Psychopharmacol 11: 177–185.

2. Bollini P, Pampallona S, Tibaldi G, Kupelnick B, Munizza C (1999). Effectiveness of antidepressants. Meta-analysis of dose effect relationships in randomized clinical trials. Br J Psychiatry 174: 297–303.

3. US Congress (1996). Freedom of Information Act. 5 US Congress. 552 (1994 & Supp. II 1996). Available at http://www.usdoj.gov/04foia/ . Accessed January 21, 1999. Br J Psychiatry 174: 297–303.

4. Gram LF (1990). Inadequate dosing and pharmacokinetic variability as confounding factors in assessment of efficacy of antidepressants. Clin Neuropharmacol 3: S35–44.

5. Khan A, Khan S, Leventhal R, Brown WA (2001). Symptom reduction and suicide risk in patients treated with placebo in antidepressant clinical trials: a replication analysis of the food and drug administration database. Int J Neurosychopharmacol 4: 113–118.

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