Generalized Anxiety DisorderPhase 4NCT00902564
Escitalopram in Patients With Generalized Anxiety Disorder
A Phase 4 study testing Escitalopram in people with Generalized Anxiety Disorder, run by H. Lundbeck A/S at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- Mar 2009to Mar 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Escitalopram in Patients With Generalized Anxiety Disorder; Open-label, One Arm Postmarketing Study in Russia
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.
Read the detailed description
The study will be performed in Russia, as an open-label, uncontrolled, one arm trial. The patients will receive escitalopram for 8 weeks. Start and maintenance dosages as well as dose titration will be left to the investigators' decision (5 to 20 mg/day), in accordance with the national Summary of Products Characteristics (SPC).
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Escitalopram
- Keywords
- Generalized Anxiety Disorder, GAD, Antidepressant, Anxiolytic
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Cipralex, Lexapro
Flexible-dosed (5 to 20 mg Oral Tablets Daily)
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Experimental | Not described Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 8 weeks
Secondary outcomes (8)
Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-I)
The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: baseline and 8 weeks
Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-S)
The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).
Measured: baseline and 8 weeks
Percentage of Patients Who Responded to Escitalopram After 8 Weeks of Treatment Using CGI-I <= 2
The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: baseline and 8 weeks
Percentage of Patients Who Achieved Remission After 8 Weeks of Treatment Using CGI-S <= 2
The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).
Measured: baseline and 8 weeks
Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Work
The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.
Measured: baseline and 8 weeks
Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Family
The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.
Measured: baseline and 8 weeks
Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Social
The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.
Measured: baseline and 8 weeks
Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score
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.
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902564
- Sponsor's protocol ID
- 12132A
- Status last verified
- May 2011
- First submitted
- 14 May 2009
- Last updated
- 10 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Escitalopram in Patients With Generalized Anxiety Disorder; Open-label, One Arm Postmarketing Study in Russia
- ClinicalTrials.gov ID
- NCT00902564
- Acronym / sponsor ID
- 12132A
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized Anxiety Disorder, GAD, Antidepressant, Anxiolytic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 15 May 2009 (estimated)
- Results
- Posted 10 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be performed in Russia, as an open-label, uncontrolled, one arm trial. The patients will receive escitalopram for 8 weeks. Start and maintenance dosages as well as dose titration will be left to the investigators' decision (5 to 20 mg/day), in accordance with the national Summary of Products Characteristics (SPC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | Experimental | Drug: Escitalopram |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscitalopramAlso: Cipralex, LexaproFlexible-dosed (5 to 20 mg Oral Tablets Daily) | Drug | Escitalopram |
Primary outcome
Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)
Time frame: baseline and 8 weeks
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.
8 secondary outcomes
Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-I)
Time frame: baseline and 8 weeks
Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-S)
Time frame: baseline and 8 weeks
Percentage of Patients Who Responded to Escitalopram After 8 Weeks of Treatment Using CGI-I <= 2
Time frame: baseline and 8 weeks
Percentage of Patients Who Achieved Remission After 8 Weeks of Treatment Using CGI-S <= 2
Time frame: baseline and 8 weeks
Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Work
Time frame: baseline and 8 weeks
Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Family
Time frame: baseline and 8 weeks
Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Social
Time frame: baseline and 8 weeks
Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score
Time frame: baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Escitalopram in people with Generalized Anxiety Disorder, run by H. Lundbeck A/S at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA) (time frame: baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2011.