STAR*D Documents

November 22, 2011

1.    STAR-D Contract dated 9/29/199; 78 pages.  Lots of interesting reading some of which I’ve highlighted.  Pages 11-13 describe the organizational structure and different committees one of whom kept NIMH’s director appraised of progress.  Pages 20-21 list the contract’s terms and conditions with provision # 10 on page 21 stating that the study findings could not be “released, presented at meetings, or published” by the investigators without the prior “review and approval” of STAR*D’s Editorial/Communication Committee and the Government Program Officer overseeing the study.

2.    STAR-D Research Protocol and Analytic Plan, Revised June 28, 2002; 112 pages.  Again, lots of interesting reading some of which I’ve highlighted.  The bottom of p.47 & top of page 48 is one of the two sections making explicit that the QIDS-SR, along with the other non-blinded clinic assessments, were excluded from use as research measures and states “The latter are designed to collect information that guides clinicians in the implementation of the treatment protocol. Research outcomes assessments are not collected at the clinic visits. They are not collected by either clinicians or CRCs.”  It is hard to be clearer than this.  Pages 55–62 describe STAR*D’s plan for comparing the cost-effectiveness of the antidepressant treatments, including their impact on clinical outcome measures, overall health care utilization, and cost of care.  There is no evidence that these planned analyses were ever conducted even though they were the essence of the study.

3.    STAR_D Clinical Procedures Manual, dated July 31st, 2002; 123 pages.  This manual is cited extensively in both the Pigott et al., 2010 and Pigott, 2011 articles.  Contains lots of critical information that was simply never disclosed in the steps 1-4 and summary articles.

4.    STAR_D Patient Education Plan Manual, dated February 2001; 11 pages.

5.    Letter to Robert Freedman, editor of the American Journal of Psychiatry.  The letter accompanied the submission of the Pigott et al. paper to AJP in April 2009; 3 pages.  This detailed letter to Freedman, specified multiple instances of bias in the AJP-published STAR*D articles that warranted correction and highlighted how an unbiased presentation of STAR*D’s findings discredits APA’s continuation phase guideline for treating depression.  The letter also offered to send Freedman my e-mail exchanges with Stephen Wisniewski, STAR*D’s chief biostatistician, confirming the accuracy of the paper’s analysis so that this information could be provided to AJP peer reviewers.  Freedman never requested the emails and the paper was rejected without any indication that it was sent out for peer-review.

6.    First Wisniewski emailconfirming my understanding of how to interpret the summary article’s survival analysis data tables.  Based on this exchange, I knew that only 108 of STAR*D’s 4,041 patients had an acute-care remission and survived follow-up.

7.    Second email exchange with Wisniewski confirming that all patients were started on Celexa in their baseline visit.

8. Correspondence related to Ed Pigott’s request that the Journal of Clinical Psychopharmacology and  Psychological Medicine retract STAR*D articles.

a) Ed Pigott’s April 5, 2011 letter to Journal of Clinical Psychopharmacology asking that the journal retract this article: McClintock et al. “Residual symptoms in depressed outpatients who respond by 50% but do not remit to antidepressant medication.”  Journal of Clinical Psychopharmacology 2011; 31:180-186.

b) Ed Pigott’s April 6, 2011 letter to Psychological Medicine asking that the journal retract this article: Nierenberg et al., Residual symptoms after remission of major depressive disorder with citalopram and risk of relapse: a STAR*D report.  Psychological Medicine 2010; 40: 41–50.

c) Reply by Journal of Clinical Psychopharmacologys editors to Pigott.

d) Reply by Psychological Medicine’s editors to Pigott.

e) Pigott’s April 20, 2011 response to the Journal of Clinical Psychopharmacologys editors.

Relevant STAR*D Published Articles

1.    Fava, M., Rush, A. J., Trivedi, M. H., Nierenberg, A. A., Thase, M. E., Sackeim, H. A., et al. (2003). Background and rationale for the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. Psychiatric Clinics of North America, 26(2), 457–494.  This article is cited extensively in both the Pigott et al., 2010 and Pigott, 2011 articles.  The article is available by emailing me @: [email protected].  

2.    Rush, A. J, Fava, M., Wisniewski, S. R., Lavori, P. W., Trivedi, M. H., Sackeim, H. A., et al. (2004). Sequenced treatment alternatives to relieve depression (STAR*D): Rationale and design. ControlledClinical Trials, 25(1), 119–142.  This article is cited extensively in both the Pigott et al., 2010 and Pigott, 2011 articles.  The article is available by emailing me @: [email protected].   

3. Pigott, H. E., Leventhal, A. M., Alter, G. S., & Boren, J. J. (2010). Efficacy and effectiveness of antidepressants: Current status of research. Psychotherapy and Psychosomatics, 79(5), 267–279.  

4. Pigott, H. E. (2011).  STAR*D: A tale and trail of bias.  Ethical Human Psychology and Psychiatry, 13(1), 6-28.  This article is available by emailing me @: [email protected]