Prospective, randomised evaluation of efficacy of antidepressant monotherapy and antidepressant combinations in the treatment of patients with resistant depression
| ISRCTN | ISRCTN65259480 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65259480 |
| Protocol serial number | IGA MZ CR NS 10368-3 |
| Sponsor | Ministry of Health (Czech Republic) - Internal Grant Agency |
| Funder | Ministry of Health (Czech Republic) - Internal Grant Agency (ref: No. NS 10368-3) |
- Submission date
- 03/09/2010
- Registration date
- 27/09/2010
- Last edited
- 27/09/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Martin Bares
Scientific
Scientific
Prague Psychiatric Center
Ústavni 91
Prague 8-Bohnice
181 03
Czech Republic
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre two arm open label randomised active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Randomised, open-label study comparing the efficacy of antidepressant monotherapy and antidepressant combinations in the acute treatment of patients with resistant depression |
| Study acronym | D-REZ-KOMB |
| Study objectives | The aim of our study is to examine efficacy of antidepressant monotherapy and combinations of antidepressants in the treatment of resistant depression in common clinical practice. We will test the following null hypotheses: 1. That the reduction of depressive symptoms does not differ between monotherapy and combinations groups 2. The number of responders in both groups does not differ |
| Ethics approval(s) | The Ethics Committee of Prague Psychiatric Centre approved on the 21st May 2008 |
| Health condition(s) or problem(s) studied | Resistant depressive disorder |
| Intervention | 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 judgment and with regard to the history of previous treatment. Antidepressant or combinations of antidepressant will be used in the dose cited in Summary of Products. Both interventions are defined as a new intervention not augmentation of previous antidepressant treatments. We will administer combinations that are commonly used in clinical practice. The total duration of treatment is 6 weeks. We will evaluate stability of outcome in responders after 2 months. |
| Intervention type | Other |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 30/06/2011 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
Prague Psychiatric Center
Prague 8-Bohnice
181 03
Czech Republic
181 03
Czech Republic
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
