E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
In total 40 subjects, aged 20-65 years, with depressive symptoms, considered by their physician to need antidepressant treatment, will be recruited from primary care clinics in the Stockholm area. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012378 |
E.1.2 | Term | Depression |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
What is the frequency of subsensitivity, normal sensitivity and increased sensitivity, respectively, using the DEX-CRH-test in depressed patients, with or without stress symptoms, in general practise?
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E.2.2 | Secondary objectives of the trial |
Another purpose of the study is to test the feasibility of a planned trial design intended to investigate the predictive power of the DEX-CRH-test in treatment of depressed patients with either citalopram or CBT. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In total 40 subjects, aged 20-65 years, with depressive symptoms (MADRS ≥12) considered by their physician to need antidepressant treatment, will be recruited from primary care clinics in the Stockholm area. All subjects must be employed. |
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E.4 | Principal exclusion criteria |
Alcohol or drug dependence, bipolar disorder, psychotic symptoms, acute suicide risk or current treatment with antidepressant drugs or psychotherapy, breastfeeding or pregnant, concomitant administration of pharmaceutical preparations containing substances which inhibit ACTH and/or cortisol, such as corticosteroids (except for dexamethasone 1.5 mg at the evening before the DEX-CRH test), antihistamines and antiserotoninergic substances and oxytocin,
subjects with concomitant administration of vasopressin or its analogues will be excluded, since these substances lead to an increase of the potency of CRH Ferring, |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in total scores on the MADRS (Montgomery-Åsberg Depression Rating Scale) and the Karolinska Exhaustion Disorder Rating Scale (KEDS) at 12 and 16 weeks after inclusion. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline and after 12 and 16 weeks |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Cognitive behavior therapy (CBT) |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |