Phobic DisordersPhase 2/3NCT00121069
Study of Escitalopram in the Treatment of Specific Phobia
A Phase 2/3 study testing Escitalopram in people with Phobic Disorders, run by Connor, Kathryn M., M.D. at 1 site in United States.
Trial summary
This pilot study is designed to assess the efficacy of escitalopram in the treatment of specific phobia in adult outpatients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Phobic Disorders
- What is being tested?
- Escitalopram
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Sep 2004
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18-65 years of age
- DSM-IV criteria for specific phobia according to the MINI
- For women of childbearing potential, a negative serum pregnancy test at screening
- Written informed consent
Who cannot join
- Any current primary DSM-IV diagnosis other than specific phobia
- History of DSM-IV substance abuse or dependence within the last months
- Lifetime history of bipolar I disorder, schizophrenia or other psychotic disorder, mental retardation, or other pervasive developmental disorder or cognitive disorder due to a general medical condition
- Suicide risk or serious suicide attempt within the last year
- Clinically significant laboratory or EKG abnormality or unstable medical condition
- For women of childbearing potential, unwillingness to use an acceptable form of contraception during the study
- Subjects needing concurrent use of psychotropic medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Dept of Psychiatry and Behvaioral Science, Duke Unviersity Medical Center
Durham, North Carolina, 27710
About this study
Official title: Placebo-Controlled Pilot Study of Escitalopram in the Treatment of Specific Phobia
This pilot study is designed to assess the efficacy of escitalopram in the treatment of specific phobia in adult outpatients.
Read the detailed description
This double-blind placebo-controlled pilot trial study is designed to assess the efficacy of 12 weeks of escitalopram vs. placebo in the treatment of specific phobia in adult outpatients. It is hypothesized that escitalopram is safe and effective in the treatment of specific phobia.
- Conditions
- Phobic Disorders
- Being tested
- Escitalopram
- Keywords
- specific phobia, anxiety, SSRI, clinical trial, escitalopram
- Medical subject headings
- Phobic Disorders, Phobia, Specific, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response based on a criterion of 50% or greater reduction in the Marks Main Phobia Questionnaire and Marks Fear Questionnaire from baseline
Secondary outcomes (1)
Response based on CGI-I category
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startSep 2002
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phobic DisordersStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Connor, Kathryn M., M.D.
- Collaborators
- Forest Laboratories
- Investigators
- Kathryn M. Connor, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121069
- Sponsor's protocol ID
- 3990-02-9
- Status last verified
- Jul 2005
- First submitted
- 13 Jul 2005
- Last updated
- 21 Jul 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled Pilot Study of Escitalopram in the Treatment of Specific Phobia
- ClinicalTrials.gov ID
- NCT00121069
- Acronym / sponsor ID
- 3990-02-9
- Conditions
- Phobic Disorders
- Keywords
- specific phobia, anxiety, SSRI, clinical trial, escitalopram
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- Connor, Kathryn M., M.D.
- Collaborators
- Forest Laboratories
- Study start
- Sep 2002
- Study completion
- Sep 2004
- First posted
- 21 Jul 2005 (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.
This pilot study is designed to assess the efficacy of escitalopram in the treatment of specific phobia in adult outpatients.
Detailed description
This double-blind placebo-controlled pilot trial study is designed to assess the efficacy of 12 weeks of escitalopram vs. placebo in the treatment of specific phobia in adult outpatients. It is hypothesized that escitalopram is safe and effective in the treatment of specific phobia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults 18-65 years of age
- DSM-IV criteria for specific phobia according to the MINI
- For women of childbearing potential, a negative serum pregnancy test at screening
- Written informed consent
Key exclusion criteria (7 listed)
- Any current primary DSM-IV diagnosis other than specific phobia
- History of DSM-IV substance abuse or dependence within the last months
- Lifetime history of bipolar I disorder, schizophrenia or other psychotic disorder, mental retardation, or other pervasive developmental disorder or cognitive disorder due to a general medical condition
- Suicide risk or serious suicide attempt within the last year
- Clinically significant laboratory or EKG abnormality or unstable medical condition
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 |
|---|---|---|
| Escitalopram | Drug | – |
Primary outcome
Response based on a criterion of 50% or greater reduction in the Marks Main Phobia Questionnaire and Marks Fear Questionnaire from baseline
1 secondary outcome
Response based on CGI-I category
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 21 Jul 2005.
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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.
Kathryn M. Connor, M.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Escitalopram in people with Phobic Disorders, run by Connor, Kathryn M., M.D. at 1 site in United States.
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 4 inclusion and 7 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 21 Jul 2005. 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 United States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Response based on a criterion of 50% or greater reduction in the Marks Main Phobia Questionnaire and Marks Fear Questionnaire from baseline. 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 21 Jul 2005.