The Dexametasone-CRH-test as a potential predictor of treatment effect in depression: a pilot study. - KIDSS

• Conditions: 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.; MedDRA version: 14.0Level: PTClassification code 10012378Term: DepressionSystem Organ Class: 10037175 - Psychiatric disorders

• Registration Number: EUCTR2010-022673-33-SE
• Lead Sponsor: Psykiatri Nordväst, Karolinska Universitetssjukhuset Solna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-19
• Last Update Posted: 7 October 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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? <br><br>;Secondary Objective: 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.;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.;Timepoint(s) of evaluation of this end point: Baseline and after 12 and 16 weeks