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The purpose of this study is to determine whether outcome following antidepressant treatment can be used as a tool to evaluate endo-phenotypes for depression.
The research in depression has for some years focused at the identification of endo-phenotypes. Endo-phenotypes are heritable biological or psychological markers, which are more commonly found in patients and their healthy relatives than in the general population.
Recent studies point at disturbed regulation of the hypothalamic-pituitary-adrenocortical (HPA) system as a possible endo-phenotype for depression.
The hypothesis of AGENDA are that endo-phenotypes are affected by treatment with antidepressants in healthy first degree relatives.
AGENDA is a four week randomized, placebo-controlled, double-blind trial in which first degree relatives of patients with the diagnosis of depression are randomised in to two groups, which are treated with either placebo or antidepressant medicine (Cipralex). We expect to include 80 healthy subjects, with the predisposition for depression, since one of their parents or siblings recently was treated for depression.
The subjects will be examined before and after four weeks of treatment by a thorough interview concerning psychiatric symptoms (SCAN), including depressive symptoms, personality, perceived stress and cognitive function. The effect of antidepressant on stress is measured with saliva-cortisol and by the response to the combined dexamethasone corticotropin-releasing (CRH) hormone test. Additionally, MR and PET scans of the 5-HT4 receptor function will be conducted before and after 4 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A Escitalopram 10 mg | Active Comparator | Escitalopram 10 mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | Escitalopram 10 mg p.o. per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the response on the combined dexamethasone corticotropin-releasing hormone test before and after 4 weeks treatment with escitalopram or placebo. | 4-6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in scores before and after 4 weeks treatment with escitalopram or placebo on: Cognition | 4-6 weeks | |
| Social function | 4-6 weeks | |
| Neuroticism |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars V Kessing, DMSc | Psychiatric Department of Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen OE | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Department of Rigshospitalet | Blegdamsvej 9 | Copenhagen OE | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22393376 | Derived | Knorr U, Vinberg M, Mortensen EL, Winkel P, Gluud C, Wetterslev J, Gether U, Kessing LV. Effect of chronic escitalopram versus placebo on personality traits in healthy first-degree relatives of patients with depression: a randomized trial. PLoS One. 2012;7(2):e31980. doi: 10.1371/journal.pone.0031980. Epub 2012 Feb 29. | |
| 21738622 |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| D003909 | Dexetimide |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Placebo | Drug | Placebo |
|
| 4-6 weeks |
| Subjective; sleep, pain, aggression, depression, anxiety, quality of life, perceived stress and side-effects | 4-6 weeks |
| Receptor status by PET-scans | 4-6 weeks |
| Inflammatory parameters | 4-6 weeks |
| Paraclinical measures | 4-6 weeks |
| MR and fMRI | 4-6 weeks |
| Knorr U, Vinberg M, Hansen A, Klose M, Feldt-Rasmussen U, Hilsted L, Hasselstrom J, Gether U, Winkel P, Gluud C, Wetterslev J, Kessing LV. Escitalopram and neuroendocrine response in healthy first-degree relatives to depressed patients--a randomized placebo-controlled trial. PLoS One. 2011;6(6):e21224. doi: 10.1371/journal.pone.0021224. Epub 2011 Jun 27. |
| 19671139 | Derived | Knorr U, Vinberg M, Klose M, Feldt-Rasmussen U, Hilsted L, Gade A, Haastrup E, Paulson O, Wetterslev J, Gluud C, Gether U, Kessing L. 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. Trials. 2009 Aug 11;10:66. doi: 10.1186/1745-6215-10-66. |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |