NCT00660062

Brief Summary

The main purpose of this study is to investigate the relapse preventing efficacy of escitalopram in a dose range and nortriptylin in a single dose in patients having been treated successfully with a course of electroconvulsive treatment (ECT).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 9, 2014

Status Verified

April 1, 2011

Enrollment Period

5.3 years

First QC Date

April 14, 2008

Last Update Submit

December 7, 2014

Conditions

Major Depression

Keywords

Major depressionrelapse preventionECTescitalopramnortriptyline

Outcome Measures

Primary Outcomes (1)

  • Hamilton depression rating scale

    14 days

Secondary Outcomes (1)

  • Drop out due to side-effects of drugs

    14 days

Study Arms (4)

Escitalopram 10 mg daily

EXPERIMENTAL

Escitalopram 10 mg daily

Drug: escitalopram

Escitalopram 20 mg daily

EXPERIMENTAL

Escitalopram 20 mg daily

Drug: escitalopram

escitalopram 30 mg daily

EXPERIMENTAL

escitalopram 30 mg daily

Drug: escitalopram

Nortriptylin 100 mg daily

ACTIVE COMPARATOR

Nortriptylin 100 mg daily

Drug: nortriptyline

Interventions

escitalopramDRUG

10 mg daily

Escitalopram 10 mg daily
nortriptylineDRUG

100 mg daily dosage

Nortriptylin 100 mg daily

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Remission from a major depressive episode after ECT treatment

You may not qualify if:

  • Suicidality (Hamilton item 3 score of 3 or more)
  • Symptoms mania (MAS score of 15 or more)
  • Duration of actual depressive episode more than 2 years
  • Compulsory measures of any kind
  • Dementia
  • Severe somatic illness
  • Pregnant or lactating subject
  • Known clinical relevant malabsorption.
  • Epilepsia
  • Clinically substantial cognitive deterioration due to ECT treatment
  • schizophrenia, schizopreniform or schizo-affective disorder
  • Bipolar I, Bipolar II eller
  • Rapid cycling bipolar disorder
  • Abuse of alcohol or drugs
  • Early relapse (less than 2 month) after ECT
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Centre Copenhagen Department O

Copenhagenl, 2100 Ø, Denmark

Location

Related Publications (2)

  • Sackeim HA, Haskett RF, Mulsant BH, Thase ME, Mann JJ, Pettinati HM, Greenberg RM, Crowe RR, Cooper TB, Prudic J. Continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a randomized controlled trial. JAMA. 2001 Mar 14;285(10):1299-307. doi: 10.1001/jama.285.10.1299.

    PMID: 11255384BACKGROUND

  • Martiny K, Larsen ER, Licht RW, Nielsen CT, Damkier P, Refsgaard E, Lunde M, Straaso B, Christensen EM, Lolk A, Holmskov J, Sorensen CH, Brodsgaard I, Eftekhari SZ, Bendsen BB, Klysner R, Terp IM, Larsen JK, Vestergaard P, Buchholtz PE, Gram LF, Bech P; Danish University Antidepressant Group (DUAG*). Relapse Prevention in Major Depressive Disorder After Successful Acute Electroconvulsive Treatment: a 6-month Double-blind Comparison of Three Fixed Dosages of Escitalopram and a Fixed Dose of Nortriptyline - Lessons from a Failed Randomised Trial of the Danish University Antidepressant Group (DUAG-7). Pharmacopsychiatry. 2015 Nov;48(7):274-8. doi: 10.1055/s-0035-1565063. Epub 2015 Nov 3.

    PMID: 26529118DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

EscitalopramNortriptyline

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Klaus Martiny, MD,PhD

    Mental Health Center Copenhagen Department O

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

April 14, 2008

First Posted

April 17, 2008

Study Start

August 1, 2009

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 9, 2014

Record last verified: 2011-04

Locations

DK(1)