EUCTR2008-003877-42-DK
Active, not recruiting
Phase 1
Relapse prevention in patients with major depression treated with electroconvulsive therapy using a fixed dose range of escitalopram compared to a fixed dose of nortriptyline (DUAG-7)A randomised controlled 6 month double-blind study - Relapse prevention with escitalopram or nortriptyline following ECT (DUAG-7)
Danish University Antidepressant Group (DUAG)0 sites300 target enrollmentOctober 28, 2008
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Danish University Antidepressant Group (DUAG)
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Remission of depression after Electroconvulsive Therapy (ECT)
- •Age above 18
- •ECT course ended within the last 21 days
- •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) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Suicidality corresponding to more than a score of more than 3 on the Hamilton depressionsskale item 3 or if project participant or investigator cannot determine the level of suicidality.
- •Manic symptoms of a severety corresponding to a score of 15 or more on the Bech\-Rafaelsen Mania scale at inclusion and at any time during the study period.
- •Duration of current depressive episode of more than 2 years.
- •Participant is under coercive measures.
- •Dementia or any other known organic brain disease than is anticipated to influence the validity of the informed consent and compliance with the study.
- •Presence of known clinical important somatic diseases supposed to be problematic in relation to study procedures.
- •Epilepsia.
- •Cognitive deterioration caused by the Electroconvulsive therapy supposed to be problematic in relation to study procedures.
- •Schizophrenia, schizoaffektive disorder or other psychotic disorder without relation to actual depressive episdoe.
- •Bipolar I, Bipolar II or Rapid cy\-cling bipolar sygdom.
Outcomes
Primary Outcomes
Not specified
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