NCT00902564

Brief Summary

The purpose of this study is to evaluate the effect of escitalopram after 8 weeks of treatment in patients with Generalized Anxiety Disorder (GAD), to evaluate proportion of patients who respond to escitalopram during the treatment period, and to evaluate safety of escitalopram.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 10, 2011

Completed
Last Updated

June 10, 2011

Status Verified

May 1, 2011

Enrollment Period

9 months

First QC Date

May 14, 2009

Results QC Date

March 14, 2011

Last Update Submit

May 11, 2011

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety DisorderGADAntidepressantAnxiolytic

Outcome Measures

Primary Outcomes (1)

  • Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)

    The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.

    baseline and 8 weeks

Secondary Outcomes (8)

  • Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-I)

    baseline and 8 weeks

  • Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-S)

    baseline and 8 weeks

  • Percentage of Patients Who Responded to Escitalopram After 8 Weeks of Treatment Using CGI-I <= 2

    baseline and 8 weeks

  • Percentage of Patients Who Achieved Remission After 8 Weeks of Treatment Using CGI-S <= 2

    baseline and 8 weeks

  • Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Work

    baseline and 8 weeks

  • +3 more secondary outcomes

Study Arms (1)

Escitalopram

EXPERIMENTAL
Drug: Escitalopram

Interventions

EscitalopramDRUG

Flexible-dosed (5 to 20 mg Oral Tablets Daily)

Also known as: Cipralex, Lexapro
Escitalopram

Eligibility Criteria

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

You may qualify if:

  • The patient suffers from GAD, diagnosed according to ICD-10 (International Classification of Diseases)
  • The patient meets criteria as set out in the national SPC for escitalopram
  • The patient is, in the opinion of the investigator, otherwise healthy on the basis of a physical examination, medical history and vital signs

You may not qualify if:

  • The patient has/has had an alcohol or drug abuse-related disorder, as defined in ICD-10
  • The patient has contraindications to escitalopram
  • The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram
  • The patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance
  • The patient is pregnant or breast-feeding
  • The patient, if a woman of childbearing potential, is not using adequate contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RU001

Moscow, Russia

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

EscitalopramDexetimide

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperidonesPiperidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Study Director
Organization
H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
Email contact via

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 14, 2009

First Posted

May 15, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

June 10, 2011

Results First Posted

June 10, 2011

Record last verified: 2011-05

Locations

RU(1)