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Flushing in Social Anxiety Disorder on Cipralex

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00485888
Recruitment Status : Completed
First Posted : June 13, 2007
Last Update Posted : October 30, 2013
H. Lundbeck A/S
Information provided by (Responsible Party):
Dr. Martin A. Katzman, START Clinic for Mood and Anxiety Disorders

Brief Summary:

To add to our understanding of the relationship between blushing, symptom severity and potential mechanisms that underlie blushing in patients with SP, we propose comparing SP patients' vascular responses to topical m-N pre and post treatment with S-citalopram or placebo.

S-citalopram (an SSRI) has been widely used in the treatment of mood and anxiety disorders as it has shown efficacy in these patients (Lepola et al., 2003; Stahl et al., 2003; Burke et al., 2002; Davidson et al., 2002; Wade et al., 2002). In comparison to placebo, S-citalopram has been shown to be effective and well tolerated in those with short and long term SP (Lader et al 2004; Montgomery et al., 2003; Kasper et al., 2002). As indicated, responses to the blushing exposure will be assessed prior to and following treatment with S-citalopram or placebo and at one month following the intervention.

Levels of prostaglandin will be compared between groups and will also be correlated with symptom severity in the clinical groups. Effective psychological interventions that reduced the fear of blushing in individuals with social phobia did not lead to a reduction in actual blushing during a social test (Mulkens et al., 2001). As such, it is expected that the patients' perception of amount of blushing will change following treatment. In addition, we are undertaking an investigation as to whether nican topical administration will change following treatment to match the pattern seen in healthy controls.

The objectives are to evaluate the efficacy of S-citalopram 10 to 20 mg once daily (QD) in the treatment of social phobia and to determine if treatment outcome is related changes in intensity of the vasodilatory response to 10 mM topical m-N. This is a randomized, double-blind flexible-dose study evaluating the efficacy, safety and tolerability of S-citalopram 10 to 20 mg and placebo in outpatient subjects diagnosed with SP. At the screening visit those who are eligible will enter a randomized trial with S-citalopram 10 to 20 mg and placebo. The study will begin with a single week of S-citalopram 10 mg. Subsequently, capsules will be administered in a flexible dose fashion and patients will be followed up weekly (biweekly after week 6) and at the clinician's discretion. After the first week the patients' dosage will be increased up to a maximum of 20 mg daily. This dose will remain fixed after 8 weeks of treatment until week 16.

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Drug: Cipralex Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Changes in the Vasodilatory Response to Methyl-nicotinate in Response to S-citalopram Treatment in Social Phobia Patients
Study Start Date : October 2008
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Phobias

Arm Intervention/treatment
Active Comparator: 1 Drug: Cipralex
10-20mg; one per day
Other Name: Escitalopram

Placebo Comparator: 2 Drug: Placebo
Matched to Cipralex

Primary Outcome Measures :
  1. Changes in intensity of the vasodilatory response to 10 mM topical m-N over 16 weeks. [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  1. Mean change from baseline on the LSAS, HAM-A, SPIN,BAI, SPS, SIAS, BTS-Q, BPS,Sheehan Disability Scale, Euroquol SF-36, PSWQ [ Time Frame: 20 weeks ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Eligible for this trial are patients who meet all of the following criteria:

    1. The patient has provided signed informed consent.
    2. Outpatients aged 18-65 (extremes included).
    3. Patients with a primary diagnosis of Social Phobia according to DSM IV (300.23) criteria (diagnosis to be made using the Mini International Neuropsychiatric Interview (MINI)).
    4. On the basis of a physical examination, medical history and basic laboratory screening, the patient is, in the investigators opinion, in a suitable condition.
    5. Willing and able to attend study appointments in the correct time windows.

Exclusion Criteria:

  • Patients meeting one or more of the following criteria cannot be selected for inclusion:

    1. Any other axis I diagnosis that was a primary disorder in the previous six months.
    2. Continuation or commencement of formal psychotherapy.
    3. Alcohol or drug abuse as defined in the DSM IV within the last six months.
    4. Mania or hypomania as defined in the DSM IV.
    5. Current use of or commencement of antidepressant and anxiolytic medications.
    6. Patients, who have been on an antidepressant or other anxiolytic prior to the study, will have discontinued it more than two weeks prior to entry into the study. Those who have been on fluoxetine, will have been off of it for at least 5 weeks
    7. Patients who have been on an herbal or alternative treatment judged to be potentially anxiolytic or with psychobiological activity, will have terminated usage of the agent more than two weeks prior to entering the study.
    8. Previous reaction to Niacin administration
    9. Use of a non-steroidal anti-inflammatory
    10. Any psychotic disorder.
    11. Eating disorders as defined in the DSM IV.
    12. Mental retardation or other cognitive disorder.
    13. Clinical interpretation of apparent suicide risk.
    14. Laboratory values at screening or in medical history that may be considered through clinical interpretation to be significant.
    15. Diseases which could, through clinical interpretation, interfere with the assessments of safety, tolerability and efficacy.
    16. Serious illness: Liver or renal insufficiency, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic or metabolic disturbance.
    17. The patient is, in the opinion of the investigator, unlikely to be able to comply with the clinical trial protocol, or is unsuitable for any other reasons.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00485888

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Canada, Ontario
START Clinic for the Mood and Anxiety Disorders
Toronto,, Ontario, Canada, M4W 2N4
Sponsors and Collaborators
START Clinic for Mood and Anxiety Disorders
H. Lundbeck A/S
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Principal Investigator: Martin A Katzman, MD START Clinic for the Mood and Anxiety Disorders
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Responsible Party: Dr. Martin A. Katzman, Principal Investigator, START Clinic for Mood and Anxiety Disorders Identifier: NCT00485888    
Other Study ID Numbers: LuCipMNSP
First Posted: June 13, 2007    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2008
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Phobic Disorders
Phobia, Social
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs