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Trials  2009 

Rationale and design of the participant, investigator, observer, and data-analyst-blinded randomized AGENDA trial on associations between gene-polymorphisms, endophenotypes for depression and antidepressive intervention: the effect of escitalopram versus placebo on the combined dexamethasone-corticotrophine releasing hormone test and other potential endophenotypes in healthy first-degree relatives of persons with depression

DOI: 10.1186/1745-6215-10-66

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Abstract:

The AGENDA trial is designed as a participant, investigator, observer, and data-analyst-blinded randomized trial. Participants are 80 healthy first-degree relatives of patients with depression. Participants are randomized to escitalopram 10 mg per day versus placebo for four weeks. Randomization is stratified by gender and age. The primary outcome measure is the change in plasma cortisol in the dexamethasone-corticotrophin releasing hormone test at entry before intervention to after four weeks of intervention. With the inclusion of 80 participants, a 60% power is obtained to detect a clinically relevant difference in the primary outcome between the intervention and the placebo group. Secondary outcome measures are changes from baseline to four weeks in scores of: 1) cognition and 2) neuroticism. Tertiary outcomes measures are changes from baseline to four weeks in scores of: 1) depression and anxiety symptoms; 2) subjective evaluations of depressive symptoms, perceived stress, quality of life, aggression, sleep, and pain; and 3) salivary cortisol at eight different timepoints during an ordinary day. Assessments are undertaken by assessors blinded to the randomization group.Local Ethics Committee: H-KF 307413Danish Medicines Agency: 2612-3162.EudraCT: 2006-001750-28.Danish Data Agency: 2006-41-6737.ClinicalTrials.gov: NCT 00386841Robins and Guze described five phases in the development of a valid classification of psychiatric illness: clinical description, laboratory studies, delimitation from other disorders, follow-up studies and family studies [1]. Later, response to treatment was added as a sixth phase [2]. Recently, the endophenotype concept has emerged as a strategic tool in neuropsychiatric research [3].Endophenotypes are quantifiable components in the "genes-to-behaviours" pathways distinct from psychiatric symptoms [3]. In parallel with the classification of psychiatric diseases, endophenotypes are validated by specificity, state independence, heritability,

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