The predictors of response to antidepressant treatment in patients with resistant depression-an integrative approach

The predictors of response to antidepressant treatment in patients with resistant depression-an integrative approach - open-label, prospective study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN25983493

Enrollment

Registered

2013-06-27

Start date

2013-05-01

Completion date

Unknown

Last updated

2019-02-11

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

Conditions

More than one previous unsuccessful antidepressant trial lasting 4 or more weeks in the current episode of depression Mental and Behavioural Disorders Depressive episode, unspecified

Interventions

Subjects will be treated with selective serotonin reuptake inhibitors. Specific antidepressant will be chosen by attending psychiatrist according to clinical judgement and with regard to the history o

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 the American Psychiatric Association-IV. revision (DSM-IV) criteria, confirmed using The Mini-International Neuropsychiatric Interview - M.I.N.I., Czech version 5.0.0. 2. Patients fulfilling at least Stage I (=1 previous, unsuccessful, adequate, antidepressant treatment) criteria for resistant depression according to Thase and Rush. 3. The mental ability to understand and sign Informed Consent Form. 4. The score in the Montgomery and Åsberg Rating Scale (MADRS) =25 and the score in Clinical Global Impression (CGI)=4. 5. Inpatients. 6. Age between 18 and 65 years, either sex

Exclusion criteria

Exclusion criteria: 1. Contraindications of treatment with selective serotonin reuptake inhibitors (SSRIs) (citalopram, escitalopram, fluoxetine, fluvoxamine, sertraline, paroxetine) according to Summary of Product (SPC) 2. Psychiatric comorbidity on axis I and II according to DSM IV in the 6 months before enrollment to the study 3. Patients with severe somatic disorders (cardiovascular disease, neoplasms, endocrinology disorders etc.) that could be associated with depression due to somatic disease. 4. Patients treated with electroconvulsive therapy less than 3 month before enrollment or suffering from neurologic disorder (e.g., epilepsy, head trauma with loss of consciousness) and patients using any treatment which can strongly affect EEG. 5. Patients who were treated unsuccessfully with more than one SSRIs during index episode.

Design outcomes

Primary

Measure	Time frame
The ratio of occurrence of a priory defined predictors in responders and non-responders: 1. The reduction of MADRS score =20% at week 1 compared to baseline 2. The reduction of MADRS score =20% at week 2 compared to baseline 3. Reduction of prefrontal cordance value at week 1 compared to baseline, 4. The increase of pBDNF at week 1 compared to baseline 5. The increase of sBDNF at week 1 compared to baseline	—

Measure

Time frame

The ratio of occurrence of a priory defined predictors in responders and non-responders: 1. The reduction of MADRS score =20% at week 1 compared to baseline 2. The reduction of MADRS score =20% at week 2 compared to baseline 3. Reduction of prefrontal cordance value at week 1 compared to baseline, 4. The increase of pBDNF at week 1 compared to baseline 5. The increase of sBDNF at week 1 compared to baseline

—

Secondary

Measure	Time frame
The correlation of predictors value change at week 1 or 2 and the change of MADRS score at the end of study.	—

Countries

Czech Republic

Outcome results

None listed

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