Phobia, SocialPhase 4NCT00182533
Sertraline in Generalized Social Phobia With Co-Occurring Anxiety and Mood Disorders
A Phase 4 study testing Sertraline in people with Phobia, Social and Panic Disorder, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Selective serotonin reuptake inhibitors (SSRIs) including sertraline have been found to be effective in the treatment of generalized social phobia (GSP). However, virtually all of the current treatment studies with medicines, including the SSRIs, have excluded patients with social phobia who have other co-occurring… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Phobia, Social, Panic Disorder, Agoraphobia
- What is being tested?
- Sertraline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2002to Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient with primary Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) GSP plus at least one of the following comorbid DSM-IV anxiety disorders:
- panic disorder with agoraphobia
- obsessive compulsive disorder
- major depressive disorder
- generalized anxiety disorder
- Score on LSAS > 50
- Score on MADRS < 25
Who cannot join
- Any other primary AXIS-I diagnosis
- Criteria for alcohol/substance abuse/dependence
- History (Hx) of bipolar disorder, schizophrenia or other psychotic disorder
- A comorbid Axis II cluster A personality disorder
- Current increased risk of concomitant suicide
- Allergy/previous intolerance during an adequate trial (50mg/day for minimum of 4 weeks) of sertraline
Show all 10Show fewer
- Participation in any clinical trial 30 days prior to entering the study
- Unable to tolerate being free of/shows signs of withdrawal from benzodiazepines for 4 weeks
- Hx of seizures
- Thyroid problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sertraline in the Treatment of Generalized Social Phobia With Comorbidity
Selective serotonin reuptake inhibitors (SSRIs) including sertraline have been found to be effective in the treatment of generalized social phobia (GSP). However, virtually all of the current treatment studies with medicines, including the SSRIs, have excluded patients with social phobia who have other co-occurring conditions. In fact, 80% of individuals suffering with primary social phobia have at least one other anxiety. This study will evaluate the safety and efficacy of sertraline in the treatment of generalized social phobia with co-occurring anxiety and mood disorders.
- Conditions
- Phobia, Social, Panic Disorder, Agoraphobia, Obsessive-Compulsive Disorder, Anxiety Disorders, Major Depressive Disorder
- Being tested
- Sertraline, Placebo
- Keywords
- Generalized social phobia, Comorbid panic disorder with agoraphobia, Comorbid obsessive compulsive disorder, Comorbid generalized anxiety disorder, Comorbid major depressive disorder/Dysthymia
- Medical subject headings
- Phobia, Social, Panic Disorder, Agoraphobia, Obsessive-Compulsive Disorder, Anxiety Disorders, Depressive Disorder, Major, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called Zoloft
25 - 200 mg/day x 16 weeks
PlaceboDrug
25 - 200 mg/day x 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sertraline Receives: Drug: Sertraline |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression - Improvement ≤ 2
Measured: 16 weeks
Liebowitz Social Anxiety Scale [LSAS] (mean change from baseline)
Measured: 16 weeks
Secondary outcomes (10)
Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire
Measured: 16 weeks
Sheehan Disability Scale
Measured: 16 weeks
Social Phobia Scale
Measured: 16 weeks
Brief Social Phobia Scale
Measured: 16 weeks
Penn State Worry Questionnaire
Measured: 16 weeks
Panic and Agoraphobia Scale
Measured: 16 weeks
Davidson Trauma Scale
Measured: 16 weeks
Social Anxiety Spectrum Self-Report (SHY-SR)
Measured: 16 weeks
Yale-Brown Obsessive Compulsive Scale
Measured: 16 weeks
Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJul 2002
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: Study drug could not be re-supplied
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phobia, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Michael Van Ameringen, MD, FRCPC, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182533
- Sponsor's protocol ID
- 02-195
- Status last verified
- Mar 2017
- First submitted
- 14 Sep 2005
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sertraline in the Treatment of Generalized Social Phobia With Comorbidity
- ClinicalTrials.gov ID
- NCT00182533
- Acronym / sponsor ID
- 02-195
- Conditions
- Phobia, Social, Panic Disorder, Agoraphobia, Obsessive-Compulsive Disorder, Anxiety Disorders, Major Depressive Disorder
- Keywords
- Generalized social phobia, Comorbid panic disorder with agoraphobia, Comorbid obsessive compulsive disorder, Comorbid generalized anxiety disorder, Comorbid major depressive disorder/Dysthymia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study drug could not be re-supplied
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jul 2002
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Selective serotonin reuptake inhibitors (SSRIs) including sertraline have been found to be effective in the treatment of generalized social phobia (GSP). However, virtually all of the current treatment studies with medicines, including the SSRIs, have excluded patients with social phobia who have other co-occurring conditions. In fact, 80% of individuals suffering with primary social phobia have at least one other anxiety. This study will evaluate the safety and efficacy of sertraline in the treatment of generalized social phobia with co-occurring anxiety and mood disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SertralineSertraline |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Outpatient with primary Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) GSP plus at least one of the following comorbid DSM-IV anxiety disorders:
- Score on LSAS > 50
- Score on MADRS < 25
Key exclusion criteria (10 listed)
- Any other primary AXIS-I diagnosis
- Criteria for alcohol/substance abuse/dependence
- History (Hx) of bipolar disorder, schizophrenia or other psychotic disorder
- A comorbid Axis II cluster A personality disorder
- Current increased risk of concomitant suicide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SertralineAlso: Zoloft25 - 200 mg/day x 16 weeks | Drug | 1 |
| Placebo25 - 200 mg/day x 16 weeks | Drug | 2 |
Primary outcome
Clinical Global Impression - Improvement ≤ 2
Time frame: 16 weeks
Liebowitz Social Anxiety Scale [LSAS] (mean change from baseline)
Time frame: 16 weeks
10 secondary outcomes
Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire
Time frame: 16 weeks
Sheehan Disability Scale
Time frame: 16 weeks
Social Phobia Scale
Time frame: 16 weeks
Brief Social Phobia Scale
Time frame: 16 weeks
Penn State Worry Questionnaire
Time frame: 16 weeks
Panic and Agoraphobia Scale
Time frame: 16 weeks
Davidson Trauma Scale
Time frame: 16 weeks
Social Anxiety Spectrum Self-Report (SHY-SR)
Time frame: 16 weeks
Yale-Brown Obsessive Compulsive Scale
Time frame: 16 weeks
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: Study drug could not be re-supplied). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Van Ameringen, MD, FRCPC principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sertraline in people with Phobia, Social and Panic Disorder, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study drug could not be re-supplied). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression - Improvement ≤ 2 (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.