Flushing in Social Anxiety Disorder on Cipralex

NCT00485888 | Completed Phase 2

• 1 other identifier: LuCipMNSP
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Changes in intensity of the vasodilatory response to 10 mM topical m-N over 16 weeks.

  20 weeks

Secondary Outcomes (1)

• Mean change from baseline on the LSAS, HAM-A, SPIN,BAI, SPS, SIAS, BTS-Q, BPS,Sheehan Disability Scale, Euroquol SF-36, PSWQ

  20 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Cipralex

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Cipralex DRUG

10-20mg; one per day

Also known as: Escitalopram

1

Placebo DRUG

Matched to Cipralex

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible for this trial are patients who meet all of the following criteria:
• The patient has provided signed informed consent.
• Outpatients aged 18-65 (extremes included).
• 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)).
• On the basis of a physical examination, medical history and basic laboratory screening, the patient is, in the investigators opinion, in a suitable condition.
• Willing and able to attend study appointments in the correct time windows.

You may not qualify if:

• Any other axis I diagnosis that was a primary disorder in the previous six months.
• Continuation or commencement of formal psychotherapy.
• Alcohol or drug abuse as defined in the DSM IV within the last six months.
• Mania or hypomania as defined in the DSM IV.
• Current use of or commencement of antidepressant and anxiolytic medications.
• 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
• 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.
• Previous reaction to Niacin administration
• Use of a non-steroidal anti-inflammatory
• Any psychotic disorder.
• Eating disorders as defined in the DSM IV.
• Mental retardation or other cognitive disorder.
• Clinical interpretation of apparent suicide risk.
• Laboratory values at screening or in medical history that may be considered through clinical interpretation to be significant.
• Diseases which could, through clinical interpretation, interfere with the assessments of safety, tolerability and efficacy.

Sponsors & Collaborators

• START Clinic for Mood and Anxiety Disorders: lead
• H. Lundbeck A/S: collaborator

Study Sites (1)

START Clinic for the Mood and Anxiety Disorders

Toronto, Ontario, M4W 2N4, Canada

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

Dexetimide; Escitalopram

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Martin A Katzman, MD

  START Clinic for the Mood and Anxiety Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2007
• First Posted: June 13, 2007
• Study Start: October 1, 2008
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 30, 2013

Record last verified: 2008-10

Locations

CA (1)