Major Depression MedDRA version: 12.0 Level: LLT Classification code 10057840 Term: Major depression
Conditions
Interventions
Trade Name: Remergil SolTab
Product Name: Mirtazapine
Pharmaceutical Form: Soluble tablet
INN or Proposed INN: MIRTAZAPINE
CAS Number: 61337-67-5
Concentration unit: mg milligram(s)
Concentration type
Sponsors
LWL University Hospital Bochum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · male and female inpatients, 18 to 65 years of age · patients must have a diagnosis of moderate or severe major depression without psychotic or catatonic features as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV: 296.22, 296.23, 296.32, 296.33), and confirmed by the Structured Clinical Interview for DSM (SCID-I) · Hamilton Depression Rating Scale (HamD-17) score = 18 · female patients must test negative for pregnancy and, if of childbearing potential, must be using a highly effective method of birth control (Pearl Index =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · patients in whom treatment with mirtazapine is relatively or absolutely clinically contraindicated · patients who have received an experimental drug or used an experimental medical device for any indication within 30 days prior to Visit 1 · patients who have a history of inadequate response to an adequate treatment with mirtazapine, in the opinion of the investigator · patients who require concomitant treatment with any other medication with primary central nervous system activity, other than benzodiazepines · patients at risk of suicide (e.g. history of any suicide attempts, any current suicidal intent including plan) · DSM-IV diagnosis of dementia, schizophrenia spectrum disorder, bipolar affective disorder, cluster A or cluster B personality disorder, substance use disorder (abuse and dependence), and some forms of anxiety disorders (acute panic disorder, acute agoraphobia, acute social phobia, and acute general anxiety disorder), eating disorders (anorexia and bulimia nervosa) · history of convulsion or seizure disorder · severe physical disabilities · female patients who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study · aminotransferase levels > 2 times upper limit of normal (ULN) at Visit 1 · thyroid-stimulating hormone (TSH) > 10% above the ULN at Visit 1 · clinically significant ECG abnormalities at Visit 1 · patients with acute, serious, or unstable medical conditions · employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to investigate short-term antidepressant effects of an adjuvant standard occupational therapy group program in comparison with a non-therapeutic play group condition in in-patients with major depression, concurrently being treated with mirtazapine.;Secondary Objective: Secondary objectives are: · to assess and to compare antidepressive response within both groups at weeks 3 and 6 as measured by a HamD score reduction of = 50 %; · to quantify effects of add-on occupational therapy on the levels of psycho-social functioning and abilities as well as coping with demands of daily living, and to check the relationship between these measures and the primary outcome parameter; · to measure effects of add-on occupational therapy on psychomotor functioning and coordination (kinematic analysis of handwriting movements); · to measure patients’ satisfaction with the occupational program, compared with the play group condition; · to generate hypotheses on the cost-benefit ratio of standard occupational therapy; · and, to study gender differences concerning all treatment outcome parameters.;Primary end point(s): · changes in the Hamilton Depression Rating Scale (HamD) from baseline to endpoint (Day 42) and from baseline to interim weekly visits (Day 1 to 21) · improvement of psychosocial functioning and abilities as well as coping with demands of daily living · improvement of psychomotor functioning and coordination | — |
Countries
Germany
Outcome results
None listed