The DOI matches its Crossref record; 1 of the 1 references it cites were found in a registry or an index.
Symptom Reduction and Suicide Risk in Patients Treated With Placebo in Antidepressant Clinical Trials: An Analysis of the Food and Drug Administration Database
Abstract
The assumption that depressed patients who are assigned to placebo in antidepressant clinical trials are exposed to substantial morbidity and mortality is not based on research data. We assessed suicides, suicide attempts, and depressive symptom reduction in studies of 7 new antidepressants using the Food and Drug Administration database. Among 19,639 participating patients, 34 committed suicide (0.8% per year), and 130 attempted suicide (2.9% per year). Rates of suicide and attempted suicide did not differ significantly among the placebo- and drug-treated groups. Annual rates of suicide and attempted suicide were 0.4% and 2.7% with placebo, 0.7% and 3.4% with active comparators, and 0.8% and 2.8% with investigational antidepressants, respectively. Symptom reduction was 40.7% with investigational drugs (n = 4,510), 41.7% with active comparators (n = 1,416), and 30.9% with placebo (n = 2,805). These data may help inform discussions about the use of placebo in antidepressant clinical trials.
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Cites
Hamilton, M. (1960) · Journal of Neurology, Neurosurgery & Psychiatry · doi:10.1136/jnnp.23.1.56 · Cited by 32,817
Cited by
O’Reardon, J. P., Solvason, H. B., Janicak, P. G., Sampson, S., Isenberg, K. E., Nahas, Z., McDonald, W. M., Avery, D., Fitzgerald, P. B., Loo, C., et al. (2007) · Biological Psychiatry · doi:10.1016/j.biopsych.2007.01.018 · Cited by 1,910
Placebo Response in Studies of Major Depression: Variable, Substantial, and Growing
Walsh, B. T., Seidman, S. N., Sysko, R., & Gould, M. (2002) · JAMA · doi:10.1001/jama.287.14.1840 · Cited by 1,109
Suicidality in Pediatric Patients Treated With Antidepressant Drugs
Hammad, T. A., Laughren, T., & Racoosin, J. (2006) · Archives of General Psychiatry · doi:10.1001/archpsyc.63.3.332 · Cited by 1,054
Cusack, K., Jonas, D. E., Forneris, C. A., Wines, C., Sonis, J., Middleton, J. C., Feltner, C., Brownley, K. A., Olmsted, K. R., Greenblatt, A., et al. (2016) · Clinical Psychology Review · doi:10.1016/j.cpr.2015.10.003 · Cited by 865
Decreased risk of suicides and attempts during long‐term lithium treatment: a meta‐analytic review
Baldessarini, R. J., Tondo, L., Davis, P., Pompili, M., Goodwin, F. K., & Hennen, J. (2006) · Bipolar Disorders · doi:10.1111/j.1399-5618.2006.00344.x · Cited by 753
Metadata
- Authors
- Khan, A., Warner, H. A., & Brown, W. A.
- Venue
- Archives of General Psychiatry
- Publisher
- American Medical Association (AMA)
- Published
- 2000-04-01
- Volume
- 57
- Issue
- 4
- Pages
- 311
- ISSN
- 0003-990X (ISSN-L)
- OpenAlex
- W2031918577
- Cited by
- 477
- References
- 1
- FWCI
- 56.49
- Type
- journal article
- Language
- en
- Open access
- closed
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- Khan, A., Warner, H. A., & Brown, W. A. (2000). Symptom Reduction and Suicide Risk in Patients Treated With Placebo in Antidepressant Clinical Trials: An Analysis of the Food and Drug Administration Database. Archives of General Psychiatry. https://doi.org/10.1001/archpsyc.57.4.311
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