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11 February 2012
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| [ Print-friendly version ] |
| Antiglucocorticoid augmentation of antiDepressants in Depression: the ADD study |
| ISRCTN | ISRCTN45338259 |
| ClinicalTrials.gov identifier | NCT01375920 |
| Public title | Antiglucocorticoid augmentation of antiDepressants in Depression: the ADD study |
| Scientific title | Antiglucocorticoid augmentation of antiDepressants in Depression: a double-blind randomised placebo-controlled parallel group trial |
| Acronym | ADD |
| Serial number at source | EME 08/43/39 |
| Study hypothesis |
That a three week course of metyrapone (versus placebo) augmentation of antidepressants in depressed patients who have failed to respond to at least two courses of antidepressants, in primary care and psychiatric outpatient clinics in the UK will be lead to a reduction in symptoms of depression.
Link to EME project website: http://www.eme.ac.uk/projectfiles/084339info.pdf Please note, as of 16/06/2011 various updates have been made to this trial and can be found under this date in the relevant fields below. The anticipated start date has been updated from 01/01/2010 to 01/02/2011. The anticipated end date has been extended from 31/12/2011 to 01/05/2013. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Sunderland Research Ethics Committee on 22/04/2010 (ref: 10/H0904/9) |
| Study design | Double-blind randomised placebo-controlled parallel group trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Major depression |
| Participants - inclusion criteria |
Current inclusion criteria as of 16/06/2011:
1. Males and females aged 18-65 years 2. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) confirmed diagnosis of major depression 3. Severity - Patients must have a Hamilton Depression Rating Scale (HDRS17) score of 18 or greater, consistent with a moderate to severe episode. The stability of the patients' clinical state will also be confirmed with a 2 week baseline lead in period (week -2 to 0). A repeat HDRS17 score at time 0 is required to be 18 or greater. 4. Treatment refractoriness - assessed using the Massachusetts General Hospital (MGH) staging method. This defines minimum effective doses of all currently available antidepressants and an "adequate trial" as being for at least 6 weeks. For the trial to be considered as a "failure" it must have been considered by the clinical team to have been ineffective rather than the drug not taken or not tolerated. For inclusion, patients will have failed to have responded to at least their second trial of an antidepressant. This equates to a minimum score of 2 on MGH staging. The maximum MGH score for inclusion in the study will be 10. 5. At trial entry, patients must be taking monotherapy or combination antidepressant therapy that includes a serotonergic drug (a selective serotonin reuptake inhibitor [SSRI], a tertiary amine tricyclic, venlafaxine, duloxetine or mirtazepine). (Added 16/06/2011: They must not be on noradrenergic antidepressant monotherapy (eg. lofepramine, imipramine or reboxitene)). Previous inclusion criteria: 1. Males and females aged 18 - 70 years 3. Severity - Patients must have a Hamilton Depression Rating Scale (HDRS17) score of 18 or greater, consistent with a moderate to severe episode. The stability of the patients' clinical state will also be confirmed with a 2 week baseline lead in period (week 2 to 0). A repeat HDRS17 score at time 0 is required to be 18 or greater. |
| Participants - exclusion criteria |
1. Any other DSM IV Axis I disorder
2. Physical co-morbidity which would render the use of metyrapone inappropriate, including untreated hypothyroidism, disorders of steroid production, cardiac failure, angina, myocardial infarction within the last 3 years, renal failure 3. Pregnancy - determined by history and if indicated, urine pregnancy test 4. Mothers who are breastfeeding (Added 21/06/2011) 5. Use of concomitant medication that would interfere in a pharmacodynamic or pharmacokinetic manner with metyrapone 6. Dependence on alcohol or other drug in the past 12 months and/or current harmful use of alcohol or other drug 7. Recently having taken part in another research study that could interfere with the results of this one (Added 21/06/2011) |
| Anticipated start date | 01/02/2011 |
| Anticipated end date | 01/05/2013 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 190 patients will be randomised into two groups of 95 |
| Interventions | Metyrapone 500 mg twice a day or twice daily placebo for 21 days in addition to the patient's current ongoing psychotropic medication which will remain stable throughout the trial. |
| Primary outcome measure(s) | Change in clinical symptoms of depression from 0 to +5 weeks (i.e. two weeks after end of treatment), assessed by the Montgomery-Asberg Depression Research Scale (MADRS) |
| Secondary outcome measure(s) |
Current secondary outcome measures as of 16/06/2011:
1. Secondary outcomes related to mood will be the MADRS measured at time +3, +8, +16 and + 24 weeks relative to baseline 2. Quality of lfe, assessed using the EQ-5D at weeks 0, +3, +5, +8, +16, +24 3. Cortisol awakening response (CAR) from salivary samples at weeks 0, +3 and +5 Previous secondary outcome measures: 2. Quality of life, assessed using the EQ-5D at weeks 0, +3 and +5 |
| Sources of funding | Medical Research Council (MRC)/National Institutes of Health Research (NIHR) (UK) - Efficacy and Mechanism Evaluation (EME) Programme (ref: EME 08/43/39) |
| Trial website | http://www.TheADDStudy.co.uk |
| Publications | |
| Contact name | Prof Ian Nicol Ferrier |
| Address |
Academic Psychiatry
Campus for Ageing and Vitality Westgate Road |
| City/town | Newcastle Upon Tyne |
| Zip/Postcode | NE4 6BE |
| Country | United Kingdom |
| Tel | +44 (0)191 2563248 |
| i.n.ferrier@ncl.ac.uk | |
| Sponsor | Northumberland, Tyne and Wear NHS Foundation Trust (UK) |
| Address |
c/o Dr Ali Zaatar
St Nicholas Hospital Jubilee Road Gosforth |
| City/town | Newcastle Upon Tyne |
| Zip/Postcode | NE3 3XT |
| Country | United Kingdom |
| Tel | +44 (0)191 2232336 |
| Fax | +44 (0)191 223 2341 |
| ali.zaatar@ntw.nhs.uk | |
| Sponsor website: | http://www.ntw.nhs.uk |
| Date applied | 27/10/2009 |
| Last edited | 21/06/2011 |
| Date ISRCTN assigned | 21/12/2009 |
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