The DOI matches its Crossref record; 9 of the 9 references it cites were found in a registry or an index.
A double‐blind, placebo‐controlled pilot study of quetiapine for depressed adolescents with bipolar disorder
Abstract
Objective: To conduct a pilot study comparing the effects of quetiapine and placebo for the treatment of depressive episodes in adolescents with bipolar I disorder. Method: Thirty‐two adolescents (ages 12–18 years) with a depressive episode associated with bipolar I disorder were randomized to eight weeks of double‐blind treatment with quetiapine, 300–600 mg/day, or placebo. This two‐site study was conducted from March 2006 through August 2007. The primary efficacy measure was change in Children’s Depression Rating Scale–Revised Version (CDRS‐R) scores from baseline to endpoint. Secondary efficacy measures included change in CDRS‐R scores over the eight‐week study period (PROC MIXED), changes from baseline to endpoint in Hamilton Anxiety Rating Scale (HAM‐A), Young Mania Rating Scale (YMRS), and Clinical Global Impression–Bipolar Version Severity (CGI‐BP‐S) scores, as well as response and remission rates. Safety and tolerability were assessed weekly. Results: There was no statistically significant treatment group difference in change in CDRS‐R scores from baseline to endpoint (p = 0.89, effect size =−0.05, 95% confidence interval: −0.77–0.68), nor in the average rate of change over the eight weeks of the study (p = 0.95). Additionally, there were no statistically significant differences in response (placebo =67% versus quetiapine = 71%) or remission (placebo = 40% versus quetiapine = 35%) rates, or change in HAM‐A, YMRS, or CGI‐BP‐S scores (all p > 0.7) between treatment groups. Dizziness was more commonly reported in the quetiapine (41%) than in the placebo (7%) group (Fisher’s exact test, p = 0.04). Conclusions: The results suggest that quetiapine monotherapy is no more effective than placebo for the treatment of depression in adolescents with bipolar disorder. However, limitations of the study, including the high placebo response rate, may have contributed to our findings and should be considered in the design of future investigations of pharmacological interventions for this population.
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Citations
Cites
The assessment of anxiety states by rating
HAMILTON, M. (1959) · British Journal of Medical Psychology · doi:10.1111/j.2044-8341.1959.tb00467.x · Cited by 11,455
A Rating Scale for Mania: Reliability, Validity and Sensitivity
Young, R. C., Biggs, J. T., Ziegler, V. E., & Meyer, D. A. (1978) · British Journal of Psychiatry · doi:10.1192/bjp.133.5.429 · Cited by 8,744
Tohen, M., Vieta, E., Calabrese, J., Ketter, T. A., Sachs, G., Bowden, C., Mitchell, P. B., Centorrino, F., Risser, R., Baker, R. W., et al. (2003) · Archives of General Psychiatry · doi:10.1001/archpsyc.60.11.1079 · Cited by 908
Calabrese, J. R., Keck, P. E., Macfadden, W., Minkwitz, M., Ketter, T. A., Weisler, R. H., Cutler, A. J., McCoy, R., Wilson, E., Mullen, J., et al. (2005) · American Journal of Psychiatry · doi:10.1176/appi.ajp.162.7.1351 · Cited by 883
. Caution regarding the use of pilot studies to guide power calculations for study proposals.
Kraemer, H. C., Mintz, J., Noda, A., Tinklenberg, J., & Yesavage, J. A. (2006) · Archives of General Psychiatry · doi:10.1001/archpsyc.63.5.484 · Cited by 702 · cited 3×
“As described by Kraemer and colleagues (14), an effect size estimate from a small pilot study is often limited by a large standard error, which may lead to aborting studies that are worth performing and conducting studies that are underpowered.”
InfluentialThase, M. E., Macfadden, W., Weisler, R. H., Chang, W., Paulsson, B., Khan, A., & Calabrese, J. R. (2006) · Journal of Clinical Psychopharmacology · doi:10.1097/01.jcp.0000248603.76231.b7 · Cited by 559
Bridge, J. A., Birmaher, B., Iyengar, S., Barbe, R. P., & Brent, D. A. (2009) · American Journal of Psychiatry · doi:10.1176/appi.ajp.2008.08020247 · Cited by 256
CHANG, K., SAXENA, K., & HOWE, M. (2006) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1097/01.chi.0000194566.86160.a3 · Cited by 182
Self-citationOpen-Label Lithium for the Treatment of Adolescents With Bipolar Depression
PATEL, N. C., DELBELLO, M. P., BRYAN, H. S., ADLER, C. M., KOWATCH, R. A., STANFORD, K., & STRAKOWSKI, S. M. (2006) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1097/01.chi.0000194569.70912.a7 · Cited by 157
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Cited by
Yatham, L. N., Kennedy, S. H., Parikh, S. V., Schaffer, A., Bond, D. J., Frey, B. N., Sharma, V., Goldstein, B. I., Rej, S., Beaulieu, S., et al. (2018) · Bipolar Disorders · doi:10.1111/bdi.12609 · Cited by 1,852
Bahji, A., Ermacora, D., Stephenson, C., Hawken, E. R., & Vazquez, G. (2020) · Journal of Affective Disorders · doi:10.1016/j.jad.2020.03.030 · Cited by 139
Detke, H. C., DelBello, M. P., Landry, J., & Usher, R. W. (2015) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1016/j.jaac.2014.12.012 · Cited by 135
Self-citationDelBello, M. P., Goldman, R., Phillips, D., Deng, L., Cucchiaro, J., & Loebel, A. (2017) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1016/j.jaac.2017.10.006 · Cited by 135
Self-citationAntidepressants and Psychostimulants in Pediatric Populations: Is there an Association with Mania?
Goldsmith, M., Singh, M., & Chang, K. (2011) · Pediatric Drugs · doi:10.2165/11591660-000000000-00000 · Cited by 79
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Metadata
- Authors
- DelBello, M. P., Chang, K., Welge, J. A., Adler, C. M., Rana, M., Howe, M., Bryan, H., Vogel, D., Sampang, S., Delgado, S. V., Sorter, M., & Strakowski, S. M.
- Venue
- Bipolar Disorders
- Publisher
- Wiley
- Published
- 2009-07-10
- Volume
- 11
- Issue
- 5
- Pages
- 483-493
- ISSN
- 1398-5647 (ISSN-L)
- 1399-5618
- OpenAlex
- W2163880309
- Cited by
- 173
- References
- 9
- FWCI
- 8.49
- Type
- journal article
- Language
- en
- Open access
- closed
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- DelBello, M. P., Chang, K., Welge, J. A., Adler, C. M., Rana, M., Howe, M., Bryan, H., Vogel, D., Sampang, S., Delgado, S. V., Sorter, M., & Strakowski, S. M. (2009). A double‐blind, placebo‐controlled pilot study of quetiapine for depressed adolescents with bipolar disorder. Bipolar Disorders. https://doi.org/10.1111/j.1399-5618.2009.00728.x
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