Prospective, randomised evaluation of efficacy of antidepressant monotherapy and antidepressant combinations in the treatment of patients with resistant depression

Randomised, open-label study comparing the efficacy of antidepressant monotherapy and antidepressant combinations in the acute treatment of patients with resistant depression

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN65259480

Enrollment

Registered

2010-09-27

Start date

2009-01-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Resistant depressive disorder Mental and Behavioural Disorders Recurrent depressive disorder

Interventions

Patients will be randomly allocated to antidepressant monotherapy group or combination of antidepressant group. Specific antidepressant will be chosen by attending psychiatrist according to clinical j

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients suffering from major depressive disorder (recurrent or single episode) diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) criteria, confirmed using the Mini-International Neuropsychiatric Interview (MINI) Czech version 5.0.0. 2. Patients fulfilling at least Stage I criteria for resistant depression according to Thase and Rush, 1997 3. The mental ability to understand and sign Informed Consent Form 4. The score in Montgomery-Asberg Depression Rating Scale greater than or equal to 25 and the score in Clinical Global Impression greater than or equal to 4 5. Outpatients and inpatients 6. Age between 18 and 65 years

Exclusion criteria

Exclusion criteria: 1. Contraindications of used antidepressant treatments according to Summary of product (SPC) 2. The use of antidepressants as a monotherapy or as a part of combination that were ineffective in the treatment of current episode 3. The use of antipsychotics, thymostabilizers and other biological treatment of depression (ECT, rTMS, sleep deprivation etc.) during the study (anxiolytics and hypnotics for case of severe anxiety and insomnia are permitted) as well as formal psychotherapy 4. Comorbidity of Axis I and II (DSM IV) disorders in the 6 month before enrollment to the study 5. Severe or uncontrolled somatic disorders, likely to cause depressive symptoms or interfere with the conduct of the study

Design outcomes

Primary

Measure	Time frame
The change in the Montgomery-Asberg Depression Rating Scale (MADRS). Patients will be rated at baseline, week 2 week 4 and the end of acute treatment and responders after 2 month of treatment.	—

Secondary

Measure	Time frame
Response to treatment that is defined as a greater than or equal to 50% reduction of MADRS score from baseline to the end of treatment.	—

Countries

Czech Republic

Outcome results

None listed

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