Major Depressive Disorder. MedDRA version: 20.0 Level: HLGT Classification code 10012375 Term: Depressed mood disorders and disturbances System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0 Level: LLT Classification code 10045543 Term: Unipolar depression System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS System Organ Class: 10037175 - Psychiatric disorders MedDRA version:
Conditions
Interventions
Trade Name: Brintellix
Pharmaceutical Form: Tablet
INN or Proposed INN: VORTIOXETINE
CAS Number: 508233-74-7
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-20
P
Sponsors
Psychiatric Research Unit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be included if: 1) a signed informed consent is present, the patient is informed and willing to participate in the study; 2) patients are older than 18 year; 3) patients do not meet the contraindications described in exclusion criterias 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 320 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Severe Axis II and Axis III comorbidities, non-compliance, non-adherence, drug abuse or dependence are first line exclusion criteria. Other than MDD as a primary diagnosis is an exclusion criterion. Refuse to sign the inform consent for the present protocol is an exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Initially a HAMD-17 score is measured 14th days after medicine administration, thereafter 1 month 3rd, 6th, 9th and 12th month after initiation of the protocol. ;Secondary Objective: Not applicable;Primary end point(s): The primary end point for all patients are to bring them to remission of their major depression disorder. As such at least a 50% reduction in the patients initial HAMD-17 score or a totalt score below 6.;Main Objective: The hypothesis under investigation is that antidepressant drugs with different pharmacodynamic profile in comparison with the genetics of the patients are associated with a different risk of weight gain during antidepressant treatment and are associated with a different impact on the cognitive performance of MDD patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Weight gain and cognitive preformances are mearly observed and not a treatment goal. ;Timepoint(s) of evaluation of this end point: Endpoints as weight gain, cognition are likewise measured 14th days after medicine administration, thereafter 1 month 3rd, 6th, 9th and 12th month after initiation of the protocol. The genetic blood sample is taken during the protocol trial and analyzed in batches at Vejle Hospital – Genetics Department. | — |
Countries
Denmark
Contacts
Public ContactAntonio Drago
Psychiatric Research Unit
Outcome results
None listed