The subjects enrolled in the study will be major patients with major depressive disorder diagnosed according to DSM-IV, receiving electroconvulsive therapy.
Conditions
Interventions
Trade Name: Reminyl
Pharmaceutical Form: Tablet
INN or Proposed INN: GALANTAMINE
CAS Number: 357-70-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4 -
Pharmaceut
Sponsors
CUB Hospital Erasme
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects enrolled in the study will be major patients (>or= 18year) with major depressive disorder diagnosed according to DSM-IV, receiving electroconvulsive therapy. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: Exclusion criteria are refusing to participate, lack of knowledge of French or an inability to respond to a type evaluation ACE-r (illiteracy, etc.), patients Patient who are forbiden to use the treatment because of disease such as heartburn, insufficient liver or kidney, COPD or active asthma, symptomatic urinary retention, bradycardia defined as heart rate less than 60 / min or block or QTc prolongation in ECG. The patient with schizoaffective disorder, defined according to DSM-IV-TR will also be excluded. Pregnant patients or patients without contraception during the therapy will not be included in the trial. We will exclude patients with deterioration of memory before the treatment. That is to say, all the patients with MMSE less than 25. If this score is between 25 and 30, we will select patients over 82 in the ACE-r with a maximum score of obligation question Q5 and Q23 of the CEA to ensure the encoding capacity and a good recovery information before ECT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to determine the effectiveness of the prophylactic use of Galantamine 8mg in non-demented patients during an electroconvulsive treatment (ECT) to prevent the onset of cognitive impairment secondary to such treatment.;Secondary Objective: Not applicable;Primary end point(s): The cognitive status of patients will be evaluated weekly during the electroconvulsive therapy and one week, two and six months after the therapy with cognition scales: MMSE, ACE-r.;Timepoint(s) of evaluation of this end point: Weekly during the electroconvulsive therapy and one week, two and six months after the therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Drug tolerance and mood assessment scale (Hamilton 24 criteria) will be evaluated. ;Timepoint(s) of evaluation of this end point: Drug tolerance: weekly during the therapy Mood assessment scale: weekly during the therapy and one week, two and six months after the therapy. | — |
Countries
Belgium
Contacts
Public ContactLoas Gwenole
CUB Hospital Erasme/ Department of Psychiatry
Outcome results
None listed