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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-022673-33-SE
Enrollment
40
Registered
2011-07-19
Start date
2011-09-07
Completion date
Unknown
Last updated
2013-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 14.0 Level: PT Classification code 10012378 Term: Depression System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: citalopram Product Name: Citalopram Cnspharma Pharmaceutical Form: Tablet INN or Proposed INN: Dexacortal CAS Number: H02AB02 Concentration unit: mg milligram(s) Concentration type: equal

Sponsors

Psykiatri Nordväst, Karolinska Universitetssjukhuset Solna
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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,

Design outcomes

Primary

MeasureTime frame
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? ;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

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026