Generalized Anxiety DisorderN1NCT00613067
ERP N1 as a Treatment Predictor of Generalized Anxiety Disorder
A study testing escitalopram in people with Generalized Anxiety Disorder, run by Inje University at 1 site in South Korea.
Trial summary
Amplitude changes of the N1 and the N1/P2 ERP component in response to different tone intensities have been suggested as a correlative of central serotonergic activity. A strong loudness dependence amplitude increase (strong intensity dependence) reflects low serotonergic neurotransmission and vice versa. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2007to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV TR for GAD
- Hamilton Rating Scale for Anxiety (HAMA) >18
- 18 to 75 years old
Who cannot join
- Severe medical illness
- Other psychiatric illness
- HAMD > 18
- High suicidal risk
- pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Psychiatry department, Inje Univ. Ilsanpaik Hospital
Goyang, Kyunggi, 414-410
About this study
Official title: The Amplitude Change of the Auditory Evoked N1 Component as a Predictor of Response to Escitalopram Treatment in Patients With Generalized Anxiety Disorder
Amplitude changes of the N1 and the N1/P2 ERP component in response to different tone intensities have been suggested as a correlative of central serotonergic activity. A strong loudness dependence amplitude increase (strong intensity dependence) reflects low serotonergic neurotransmission and vice versa. Many researchers assumed that the brain serotonergic activity could influence treatment response of highly selective serotonin reuptake inhibitors in depression and anxiety disorders. There are a couple of studies reporting associations of N1 amplitude intensity dependence with response to Citalopram (positive correlation) and Reboxetine (negative correlation) treatment in major depressive disorder patients. But so far there have been no reports about associations between ERP N1 and antidepressant response in GAD patients.
So, it would be very interesting to explore the correlations between ERP N1 amplitude change and the Escitalopram treatment responsiveness in GAD patients.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- escitalopram
- Keywords
- Generalized anxiety disorder, N100, Central serotonergic activity
- 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 lexapro
- Start with escitalopram 10mg
- According to patient's symptoms, stay on 10mg or increase up to 20mg
- Concomitant therapy : up to Xanax 0.5mg, or Ativan 1mg, not allowed above these dosages
- Length of washout period will be at least 2 weeks for any psychotropic drugs
| Study group | Role | What they receive |
|---|---|---|
| GAD | Experimental | 35 patients with Generalized Anxiety disorder Receives: Drug: escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event related potential (ERP) N100
Measured: Baseline
Secondary outcomes (1)
- HAMA - HAMD - CGI - Beck Anxiety Inventory(self rating)
Measured: baseline, 2, 4, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Investigators
- Seung-Hwan Lee, MD, PhD, Principal investigator, Psychiatry department, Inje Univ. Ilsanpaik HospitalYoung-Min Park, MD, PhD, Study director, Psychiatry department, Inje Univ. Ilsanpaik HospitalSung-Man Bae, PhD, Study director, Psychiatry department, Inje Univ. Ilsanpaik Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613067
- Sponsor's protocol ID
- IB-0709-053
- Acronym
- N1
- Status last verified
- Jun 2010
- First submitted
- 29 Jan 2008
- Last updated
- 30 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Linka T, Muller BW, Bender S, Sartory G, Gastpar M. The intensity dependence of auditory evoked ERP components predicts responsiveness to reboxetine treatment in major depression. Pharmacopsychiatry. 2005 May;38(3):139-43. doi: 10.1055/s-2005-864126.
PubMed 15902586Linka T, Sartory G, Bender S, Gastpar M, Muller BW. The intensity dependence of auditory ERP components in unmedicated patients with major depression and healthy controls. An analysis of group differences. J Affect Disord. 2007 Nov;103(1-3):139-45. doi: 10.1016/j.jad.2007.01.018. Epub 2007 Feb 20.
PubMed 17316822Linka T, Muller BW, Bender S, Sartory G. The intensity dependence of the auditory evoked N1 component as a predictor of response to Citalopram treatment in patients with major depression. Neurosci Lett. 2004 Sep 9;367(3):375-8. doi: 10.1016/j.neulet.2004.06.038.
PubMed 15337269
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Amplitude Change of the Auditory Evoked N1 Component as a Predictor of Response to Escitalopram Treatment in Patients With Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00613067
- Acronym / sponsor ID
- N1 / IB-0709-053
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized anxiety disorder, N100, Central serotonergic activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 12 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Amplitude changes of the N1 and the N1/P2 ERP component in response to different tone intensities have been suggested as a correlative of central serotonergic activity. A strong loudness dependence amplitude increase (strong intensity dependence) reflects low serotonergic neurotransmission and vice versa. Many researchers assumed that the brain serotonergic activity could influence treatment response of highly selective serotonin reuptake inhibitors in depression and anxiety disorders. There are a couple of studies reporting associations of N1 amplitude intensity dependence with response to Citalopram (positive correlation) and Reboxetine (negative correlation) treatment in major depressive disorder patients. But so far there have been no reports about associations between ERP N1 and antidepressant response in GAD patients.
So, it would be very interesting to explore the correlations between ERP N1 amplitude change and the Escitalopram treatment responsiveness in GAD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GAD | Experimental | Drug: escitalopram35 patients with Generalized Anxiety disorder |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- DSM-IV TR for GAD
- Hamilton Rating Scale for Anxiety (HAMA) >18
- 18 to 75 years old
Key exclusion criteria (5 listed)
- Severe medical illness
- Other psychiatric illness
- HAMD > 18
- High suicidal risk
- pregnancy
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: lexapro* Start with escitalopram 10mg * According to patient's symptoms, stay on 10mg or increase up to 20mg * Concomitant therapy : up to Xanax 0.5mg, or Ativan 1mg, not allowed above these dosages * Length of washout period will be at least 2 weeks for any psychotropic drugs | Drug | GAD |
Primary outcome
Event related potential (ERP) N100
Time frame: Baseline
1 secondary outcome
- HAMA - HAMD - CGI - Beck Anxiety Inventory(self rating)
Time frame: baseline, 2, 4, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2010.
- Results publication: PubMed 15902586Linka T, Muller BW, Bender S, Sartory G, Gastpar M. The intensity dependence of auditory evoked ERP components predicts responsiveness to reboxetine treatment in major depression. Pharmacopsychiatry. 2005 May;38(3):139-43. doi: 10.1055/s-2005-864126.
- Results publication: PubMed 17316822Linka T, Sartory G, Bender S, Gastpar M, Muller BW. The intensity dependence of auditory ERP components in unmedicated patients with major depression and healthy controls. An analysis of group differences. J Affect Disord. 2007 Nov;103(1-3):139-45. doi: 10.1016/j.jad.2007.01.018. Epub 2007 Feb 20.
- Results publication: PubMed 15337269Linka T, Muller BW, Bender S, Sartory G. The intensity dependence of the auditory evoked N1 component as a predictor of response to Citalopram treatment in patients with major depression. Neurosci Lett. 2004 Sep 9;367(3):375-8. doi: 10.1016/j.neulet.2004.06.038.
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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.
Seung-Hwan Lee, MD, PhD principal investigator
Psychiatry department, Inje Univ. Ilsanpaik Hospital
Young-Min Park, MD, PhD study director
Psychiatry department, Inje Univ. Ilsanpaik Hospital
Sung-Man Bae, PhD study director
Psychiatry department, Inje Univ. Ilsanpaik Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing escitalopram in people with Generalized Anxiety Disorder, run by Inje University at 1 site in South Korea.
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 5 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 30 Jun 2010. 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Event related potential (ERP) N100 (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00613067, which also lists 3 linked publications.
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 30 Jun 2010.