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| Sponsor: | START Clinic for Mood and Anxiety Disorders |
|---|---|
| Collaborator: |
H. Lundbeck A/S |
| Information provided by: | START Clinic for Mood and Anxiety Disorders |
| ClinicalTrials.gov Identifier: | NCT00485888 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Social Anxiety Disorder |
Drug: Cipralex Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Changes in the Vasodilatory Response to Methyl-nicotinate in Response to S-citalopram Treatment in Social Phobia Patients |
| Estimated Enrollment: | 0 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Cipralex
10-20mg; one per day
Other Name: Escitalopram
|
| Placebo Comparator: 2 |
Drug: Placebo
Matched to Cipralex
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Eligible for this trial are patients who meet all of the following criteria:
Exclusion Criteria:
Patients meeting one or more of the following criteria cannot be selected for inclusion:
Contacts and Locations| Canada, Ontario | |
| START Clinic for the Mood and Anxiety Disorders | |
| Toronto,, Ontario, Canada, M4W 2N4 | |
| Principal Investigator: | Martin A Katzman, MD | START Clinic for the Mood and Anxiety Disorders |
More Information
| Responsible Party: | Dr. Katzman, Start Clinic for Mood and Anxiety Disorders |
| ClinicalTrials.gov Identifier: | NCT00485888 History of Changes |
| Other Study ID Numbers: | LuCipMNSP |
| Study First Received: | June 12, 2007 |
| Last Updated: | July 28, 2011 |
| Health Authority: | Canada: Health Canada |
|
Anxiety Disorders Phobic Disorders Mental Disorders Citalopram Dexetimide Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |