Antidepressive response to add-on occupational therapy in patients with major depression: A randomized controlled multicentre trial

• Conditions: Major Depression; MedDRA version: 12.0Level: LLTClassification code 10057840Term: Major depression

• Registration Number: EUCTR2009-016463-10-DE
• Lead Sponsor: WL University Hospital Bochum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 < 1%) before entry and throughout the study. Effective methods of birth control include oral hormonal contraceptives, contraceptive injections, contraceptive patch and male partner sterilization.
· patients in whom a minimum in-patient hospitalisation stay of at least 7 weeks (when enrolled in the study) is acceptable, in the clinical judgement of the investigator
· patients must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol
· patients must be able to understand the nature of the study and have given their own informed consent
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

· 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified