A double-blind, placebo-controlled study of the impact of prophylactic treatment with Galantamine 8mg of cognitive impairment during an electroconvulsive therapy (ECT) in patients with major depressive desorder (MDD).

Phase 1

Conditions: The subjects enrolled in the study will be major patients with major depressive disorder diagnosed according to DSM-IV, receiving electroconvulsive therapy.
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2014-004393-41-BE

Lead Sponsor: CUB Hospital Erasme

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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<br>Mood assessment scale: weekly during the therapy and one week, two and six months after the therapy.