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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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| 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: | December 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Drug: Cipralex
10-20mg; one per day
|
| 2: Placebo Comparator |
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| Contact: Martin A. Katzman, MD | 416 598 9344 | mkatzman@startclinic.ca |
| Canada, Ontario | |
| START Clinic for the Mood and Anxiety Disorders | |
| Toronto,, Ontario, Canada, M5G 1N8 | |
| Principal Investigator: | Martin A Katzman, MD | START Clinic for the Mood and Anxiety Disorders |
More Information
| Responsible Party: | Start Clinic for Mood and Anxiety Disorders ( Dr. Katzman ) |
| Study ID Numbers: | LuCipMNSP |
| Study First Received: | June 12, 2007 |
| Last Updated: | October 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00485888 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents Pathologic Processes Mental Disorders Therapeutic Uses Antidepressive Agents, Second-Generation |
Dexetimide Antidepressive Agents Disease Phobic Disorders Citalopram Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Anxiety Disorders Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |