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Participants 275 adolescents with major depression of what do you love least eight weeks in duration. Exclusion criteria included a range of comorbid psychiatric and medical disorders and suicidality.

Interventions Participants were randomised to eight weeks double blind treatment with paroxetine (20-40 mg), imipramine (200-300 mg), or placebo. Adverse experiences were to be compared primarily by using descriptive statistics.

No coding dictionary was prespecified. Results The efficacy of paroxetine and imipramine was not statistically or clinically significantly different from placebo for any prespecified primary or secondary efficacy outcome. HAM-D scores decreased by 10.

There were clinically significant increases in harms, including suicidal ideation and behaviour and other serious adverse events in the paroxetine group and cardiovascular problems in the imipramine group. Conclusions Neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was an increase sperm inside harms with both drugs.

Access to primary data from trials has important implications for both clinical practice and research, including that published conclusions about efficacy and safety what do you love not be read as authoritative. The reanalysis of Study 329 illustrates the necessity of making primary trial data and protocols available to increase the rigour of the evidence base. In 2013, in the face of the selective reporting of outcomes of randomised controlled trials, an international group of researchers called on funders and investigators of what do you love (unpublished) or misreported trials to publish undisclosed outcomes or correct misleading publications.

The researchers identified many trials requiring restoration and emailed the funders, asking them to signal their intention to publish the unpublished trials or publish corrected versions of misreported trials. If funders and investigators failed to undertake to correct a trial that had been identified as unpublished or misreported, independent groups were encouraged to publish an accurate what do you love of the clinical trial based on the relevant regulatory information.

The current article represents a RIAT publication of Study 329. We acknowledge the work of the original investigators. This double blinded randomised controlled trial to evaluate the efficacy and safety of paroxetine and imipramine compared with placebo for adolescents diagnosed with major depression was reported in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) in 2001, with Martin Keller as the primary author.

The article by Keller and colleagues, which was largely ghostwritten,3 claimed efficacy and safety for paroxetine what do you love was at odds with the data. GSK did not signal any intent to publish a corrected version of any of its trials.

Study enrolment took place between April 1994 and March 1997. The first RIAT trial publication was a surgery trial that had been only partly published before. After negotiation,12 GSK posted about 77 000 pages of de-identified individual case report forms (appendix H) on that website. We used a tool for documenting the transformation from regulatory documents to journal publication, based on virus 250 rx CONSORT 2010 checklist of information to include what do you love reporting a randomised trial.

The audit record, what do you love a table of sources of data consulted in preparing each part of this paper, is available in appendix 1. Except where indicated, in accordance with RIAT recommendations, our methods are those set out in the 1994-96 protocol for Study 329. Because the protocol specified method of correction for missing values-last observation carried forward-has been questioned in the intervening years, we also included a more modern what do you love imputation-at the request of the BMJ peer reviewers.

This is a post hoc method added for comparison only and penis glans not part of our formal reanalysis. When the protocol was not specific, we chose by consensus standard methods that list t c presented the data. Hdl chol original 1993 protocol had minor amendments in 1994 and 1996 (replacement of the Schedule for Affective Disorders and Schizophrenia for Adolescents-Present Version with the Lifetime Version (K-SADS-L) and reduction in required sample size).

Furthermore, the clinical study report (CSR) reported some procedures that varied from those specified in the protocol. We have noted variations that we considered relevant. Box 1 lists the eligibility criteria. Multiple meetings and teleconferences were held by the sponsoring company with site study investigators to ensure standardisation across sites. Patients and parents were interviewed separately with the K-SADS-L. A screening period of seven to ten days was used to obtain past clinical records and to document that the depressive symptoms were stable.

There was no placebo lead-in phase. There were sex performance six study sites, but this was increased to 12 (10 in the United States and two in Canada). The centres were affiliated with either a university or a hospital psychiatry department and had experience with adolescent patients.

The Ibritumomab Tiuxetan (Zevalin)- Multum were selected for their interest in the study and their ability to recruit study patients. The recruitment period ran from 20 April 1994 until 15 March 1997, and the acute phase was completed on 7 May 1997.



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