SAD: Geodon for the Treatment of Refractory Social Anxiety Disorder

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00215150
• Collaborator: Pfizer (Industry)
• Enrollment: 51
• Locations: 2
• Arms: 3
• Duration (Months): 56
• Patients Per Site: 25.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the effectiveness and tolerability of augmentation treatment of ziprasidone to achieve remission among patients with social anxiety disorder (SAD) who did not remit on sertraline treatment alone

Condition or Disease	Intervention/Treatment	Phase
Social Anxiety Disorder	Drug: Ziprasidone; Drug: Sertraline	Phase 2

Detailed Description

This is a two-phase study consisting of 8 weeks of open label treatment with sertraline (50-200 mg/day) in patients with SAD and in those who fail to demonstrate symptom remission on sertraline alone, 8 weeks of randomized, double-blind, placebo-controlled augmentation with ziprasidone.

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Ziprasidone for the Treatment of Refractory Social Anxiety Disorder
• Study Start Date: Nov 1, 2004
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: Open Label Treatment 8 weeks of open label treatment with sertraline	Drug: Sertraline; Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase; Other Names: Zoloft
Other: Randomization Ziprasidone 8 weeks of treatment with sertraline augmented with ziprasidone	Drug: Ziprasidone; Sertraline augmentation with ziprasidone; Other Names: Geodon ; Drug: Sertraline; Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase; Other Names: Zoloft
Other: Randomization Placebo 8 weeks of treatment with sertraline augmented by placebo	Drug: Sertraline; Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase; Other Names: Zoloft

Outcome Measures

Primary Outcome Measures

1. Brief Social Phobia Scale(BSPS) [Baseline, 8 and 16 weeks]

   An observer measure of social phobic symptoms, referred to as the Brief Social Phobia Scale, consists of 11 items, 7 evaluating commonly feared or avoided situations and 4 additional items measuring autonomic distress. A total numerical range of 0-88 is scored on this measure, with higher scores representing greater severity of social anxiety disorder symptoms.The total score is computed as a simple sum of the 11 items.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• adults 18-65 years of age

• primary diagnosis of SAD, using Diagnostic Standard Manual(DSM-IV) criteria

• minimum Clinical Global Impression of Severity (CGI-S) score of 4 at baseline

• minimum Brief Social Phobia Scale(BSPS) score of 20 at baseline

• written informed consent

• negative serum pregnancy test for women of childbearing potential

• normal EKG

Exclusion Criteria:

• current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition

• any current primary anxiety disorder other than SAD

• current primary depression

• history of substance abuse or dependence within the last 3 months

• suicide risk or serious suicide attempt within the last year

• clinically significant medical condition or laboratory or EKG abnormality

• women of childbearing potential who are unwilling to practice an acceptable method of contraception

• patients needing concurrent use of psychotropic medications

• history of hypersensitivity to sertraline or ziprasidone

• recent (less than 2 months) initiation of psychotherapy for SAD

• history of failure to respond to augmentation with an adequate trial of an atypical antipsychotic

• patients who are currently taking any of the following medications: Erythromycin, Biaxin, Avelox, Zithromax, Amantadine, Levaquin, Tamoxifen, Tegretol, Nizoral, and Levitra

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27701
2	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University
• Pfizer

Investigators

• Principal Investigator: Wei Zhang, M.D., Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Davidson JR, Potts NL, Richichi EA, Ford SM, Krishnan KR, Smith RD, Wilson W. The Brief Social Phobia Scale. J Clin Psychiatry. 1991 Nov;52 Suppl:48-51.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT00215150
• Other Study ID Numbers: Pro00012882; 6479
• First Posted: Sep 22, 2005
• Last Update Posted: Oct 31, 2014
• Last Verified: Apr 1, 2013

• Keywords provided by Duke University: anxiety disorder; SAD; ziprasidone; sertraline; antidepressant; antipsychotic
• Additional relevant MeSH terms: Disease; Anxiety Disorders; Phobia, Social; Ziprasidone; Sertraline

Study Results

Participant Flow

Recruitment Details	Recruitment was from the immediate surrounding area, by use of Institutional Review Board (IRB) approved television and radio advertisements, along with flyers.

Arm/Group Title	Open Label Treatment
Arm/Group Description	8 weeks of open label treatment with sertraline (50-200mg/day)followed by 8 weeks of randomized, Double Blind (DB), placebo-controlled augmentation with ziprasidone (40-160mg/day)for qualifying subjects.
Period Title: Open Label Phase
STARTED	51
COMPLETED	21
NOT COMPLETED	30
Period Title: Open Label Phase
STARTED	10
COMPLETED	7
NOT COMPLETED	3
Period Title: Open Label Phase
STARTED	11
COMPLETED	10
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Study Treatment
Arm/Group Description	8 weeks of open label treatment with sertraline followed by 8 weeks of treatment with ziprasidone/placebo for qualifying subjects
Overall Participants	38
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	38 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.5 (10.3)
Sex: Female, Male (Count of Participants)
Female	15 39.5%
Male	23 60.5%
Region of Enrollment (participants) [Number]
United States	38 100%

Outcome Measures

1. Primary Outcome

Title	Brief Social Phobia Scale(BSPS)
Description	An observer measure of social phobic symptoms, referred to as the Brief Social Phobia Scale, consists of 11 items, 7 evaluating commonly feared or avoided situations and 4 additional items measuring autonomic distress. A total numerical range of 0-88 is scored on this measure, with higher scores representing greater severity of social anxiety disorder symptoms.The total score is computed as a simple sum of the 11 items.
Time Frame	Baseline, 8 and 16 weeks

Outcome Measure Data

Analysis Population Description

The number of participants evaluated in either phase is based on a last observation carried forward analysis requiring at least one visit completed in addition to the first timepoint.

Arm/Group Title	Open Label Phase	Randomization Phase for Ziprasidone Group	Randomization Phase for Placebo Group
Arm/Group Description	The open label treatment phase for the first 8 weeks	The group of subjects randomized to receive Ziprasidone for the second 8 weeks	The group of subjects randomized to receive placebo for the second 8 weeks
Measure Participants	38	10	11
Beginning of Study Phase	44.0 (11.1)	31.8 (8.9)	31.8 (11.8)
End of Study Phase	31.2 (16.0)	21.0 (13.6)	24.6 (12.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Phase
	Comments	Results are from a Wilcoxon signed rank test on the difference from endpoint to baseline for the intent to treat sample from the open label phase of the project.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Wilcoxon Signed Rank Test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Randomization Phase for Ziprasidone Group, Randomization Phase for Placebo Group
	Comments	Results are from a Kruskal Wallis test on the ziprasidone/placebo groups from the randomization phase of the project.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	> .05
	Comments
	Method	Kruskal-Wallis
	Comments

Adverse Events

Arm/Group Title	Open Label Phase		Randomization Phase for Ziprasidone		Randomization Phase for Placebo
Arm/Group Description	The first 8 weeks of treatment on sertraline		The second phase of treatment with subjects randomized to ziprasidone augmentation.		The second phase of treatment with subjects randomized to placebo augmentation.
All Cause Mortality
	Open Label Phase		Randomization Phase for Ziprasidone		Randomization Phase for Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Open Label Phase		Randomization Phase for Ziprasidone		Randomization Phase for Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/10 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Open Label Phase		Randomization Phase for Ziprasidone		Randomization Phase for Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/10 (0%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.