Social Anxiety DisorderPhase 4NCT02294305
Vortioxetine Versus Placebo in Major Depressive Disorder Comorbid With Social Anxiety Disorder
A Phase 4 study testing Vortioxetine in people with Social Anxiety Disorder and Major Depressive Disorder, run by The Medical Research Network at 1 site in United States.
Trial summary
This placebo-controlled study is designed to determine the efficacy, safety, and tolerability of vortioxetine in the treatment of adults with Major Depressive Disorder (MDD) that is comorbid with Social Anxiety Disorder (SAD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Social Anxiety Disorder, Major Depressive Disorder
- What is being tested?
- Vortioxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Nov 2016
- 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
- Male and female adults between 18 and 70 years of age (inclusive).
- Subjects must give written informed consent prior to any study procedures
- Diagnosis of Major Depressive Disorder (MDD), single episode (296.2) or recurrent (296.3), according to Diagnostic and Statistical Manual of Mental Disorders, version 5 (DSM-5) criteria, as determined by psychiatric evaluation with the investigator and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
- Duration of current Major Depressive Episode must be at least 4 weeks.
- Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia) according to DSM-5 criteria, as determined by psychiatric evaluation with the Investigator and confirmed by the MINI.
- Duration of current SAD must be at least 6 months, and SAD should be observable in subjects' lives when they are not suffering from MDD, if such periods have occurred.
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- Subjects must have a minimum total score of 60 on the Liebowitz Social Anxiety Scale (LSAS) at both Screening and Baseline visits.
- Subjects must have a minimum total Montgomery Asberg Depression Rating Scale (MADRS) score of 20 at both Screening and Baseline visits.
- Subjects must have a Clinical Global Inventory (CGI) Severity score of 4 or greater at both Screening and Baseline visits, where the CGI is based on a composite of MDD and SAD.
- Male and female subjects of childbearing potential must commit to an effective form of contraception for the duration of the trial (Screening/Visit 1 through Follow-Up/Visit 10). Effective forms of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), or implantable contraceptive devices. True abstinence will also be considered an effective form of contraception.
Who cannot join
- Subjects with any lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, Obsessive Compulsive Disorder, eating disorders, or body dysmorphic disorder. Subjects with comorbid Generalized Anxiety Disorder, dysthymia, or specific phobias can be included in the study provided that MDD and SAD are considered to be the primary clinical conditions in terms of need for treatment.
- Subjects with substance abuse, panic disorder, or Post-Traumatic Stress Disorder, in the past 6 months before screening.
- Subjects who started psychotherapy for SAD or MDD or had electroconvulsive therapy (ECT) in the past 6 months before screening. Subjects who have been receiving psychotherapy or Cognitive Behavioral Therapy for more than 24 weeks prior to the Baseline visit are eligible provided that the therapy continues at the same frequency for the duration of the trial.
- Subjects who are currently pregnant or lactating, or who are of childbearing potential and not able and willing to practice an effective method of contraception (as outlined in Inclusion criterion #10) for the duration of the trial (Screening/Visit 1 through Follow-Up/Visit 10.
- Subjects who, in the opinion of the investigator, are at a clinically significant risk for suicide. This would include prominent suicidal ideation or suicidal behavior in the past 6 months before screening.
- Systolic blood pressure ≥165 and/or diastolic blood pressure ≥95, as measured at Screening and Baseline visits.
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- Positive Urine Drug Screen at the Screening visit, unless due to prescribed medication.
- Any current unstable and/or clinically significant medical condition, based on history or as evidenced in screening laboratory or electrocardiogram (ECG) assessments.
- Subjects with a history or complication of cancer or malignant tumor not in remission for at least 5 years. Basal cell skin cancers are not exclusionary.
- Subjects receiving fluoxetine within 28 days of the Baseline visit.
- Subjects receiving Monoamine oxidase inhibitors (MAOIs) within 14 days of the Baseline visit.
- Subjects receiving any other psychotropic medication (including selective serotonin re-uptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and benzodiazepines) within 14 days of the Baseline visit. Zolpidem (Ambien) PRN is allowed for insomnia if not taken more than 3 times per week for the duration of the trial.
- Treatment refractory SAD: subjects who have a history of two or more failed treatment trials with an FDA-approved SAD treatment, each given for at least 6 weeks, during which the subject received an adequate dosage
- Treatment refractory MDD: subjects who have a history of two or more failed treatment trials with an FDA-approved MDD treatment in the current episode
Trial locations and contacts
1 site in 1 country.
United States1 site
The Medical Research Network, LLC
New York, New York, 10128
About this study
This placebo-controlled study is designed to determine the efficacy, safety, and tolerability of vortioxetine in the treatment of adults with Major Depressive Disorder (MDD) that is comorbid with Social Anxiety Disorder (SAD). Half of the subjects will be randomized to receive vortioxetine and the other half will receive placebo.
- Conditions
- Social Anxiety Disorder, Major Depressive Disorder
- Being tested
- Vortioxetine, Placebo
- Keywords
- Depression, Social Anxiety, Social Phobia, Major Depression, Vortioxetine
- Medical subject headings
- Phobia, Social, Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
Also called Brintellix
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vortioxetine | Experimental | Vortioxetine 10 to 20 mg PO QD for 12 weeks. Receives: Drug: Vortioxetine |
| Placebo | Placebo comparator | Placebo PO QD for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression of Improvement (CGI-I) Responder Rate
CGI-I score of 2 (much improved) or 1 (very much improved) based on overall subject state, combining improvement in MDD and SAD features, at Visit 9/Early Termination
Measured: 12 weeks
Secondary outcomes (2)
Change in total Montgomery Asberg Depression Rating Scale (MADRS) score
Measured: Baseline and 12 Weeks
Change in total Liebowitz Social Anxiety Scale (LSAS) score
Measured: Baseline and 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Medical Research Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael R Liebowitz, M.D., Principal investigator, The Medical Research Network, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294305
- Sponsor's protocol ID
- TAK-S001560
- Status last verified
- Aug 2016
- First submitted
- 11 Nov 2014
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vortioxetine Versus Placebo in Major Depressive Disorder Comorbid With Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT02294305
- Acronym / sponsor ID
- TAK-S001560
- Conditions
- Social Anxiety Disorder, Major Depressive Disorder
- Keywords
- Depression, Social Anxiety, Social Phobia, Major Depression, Vortioxetine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Medical Research NetworkUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 19 Nov 2014 (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.
This placebo-controlled study is designed to determine the efficacy, safety, and tolerability of vortioxetine in the treatment of adults with Major Depressive Disorder (MDD) that is comorbid with Social Anxiety Disorder (SAD). Half of the subjects will be randomized to receive vortioxetine and the other half will receive placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vortioxetine | Experimental | Drug: VortioxetineVortioxetine 10 to 20 mg PO QD for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo PO QD for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female adults between 18 and 70 years of age (inclusive).
- Subjects must give written informed consent prior to any study procedures
- Diagnosis of Major Depressive Disorder (MDD), single episode (296.2) or recurrent (296.3), according to Diagnostic and Statistical Manual of Mental Disorders, version 5 (DSM-5) criteria, as determined by psychiatric evaluation with the investigator and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
- Duration of current Major Depressive Episode must be at least 4 weeks.
- Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia) according to DSM-5 criteria, as determined by psychiatric evaluation with the Investigator and confirmed by the MINI.
Key exclusion criteria (14 listed)
- Subjects with any lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, Obsessive Compulsive Disorder, eating disorders, or body dysmorphic disorder. Subjects with comorbid Generalized Anxiety Disorder, dysthymia, or specific phobias can be included in the study provided that MDD and SAD are considered to be the primary clinical conditions in terms of need for treatment.
- Subjects with substance abuse, panic disorder, or Post-Traumatic Stress Disorder, in the past 6 months before screening.
- Subjects who started psychotherapy for SAD or MDD or had electroconvulsive therapy (ECT) in the past 6 months before screening. Subjects who have been receiving psychotherapy or Cognitive Behavioral Therapy for more than 24 weeks prior to the Baseline visit are eligible provided that the therapy continues at the same frequency for the duration of the trial.
- Subjects who are currently pregnant or lactating, or who are of childbearing potential and not able and willing to practice an effective method of contraception (as outlined in Inclusion criterion #10) for the duration of the trial (Screening/Visit 1 through Follow-Up/Visit 10.
- Subjects who, in the opinion of the investigator, are at a clinically significant risk for suicide. This would include prominent suicidal ideation or suicidal behavior in the past 6 months before screening.
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 |
|---|---|---|
| VortioxetineAlso: Brintellix | Drug | Vortioxetine |
| Placebo | Drug | Placebo |
Primary outcome
Clinical Global Impression of Improvement (CGI-I) Responder Rate
Time frame: 12 weeks
CGI-I score of 2 (much improved) or 1 (very much improved) based on overall subject state, combining improvement in MDD and SAD features, at Visit 9/Early Termination
2 secondary outcomes
Change in total Montgomery Asberg Depression Rating Scale (MADRS) score
Time frame: Baseline and 12 Weeks
Change in total Liebowitz Social Anxiety Scale (LSAS) score
Time frame: Baseline and 12 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
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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 R Liebowitz, M.D. principal investigator
The Medical Research Network, LLC
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 Vortioxetine in people with Social Anxiety Disorder and Major Depressive Disorder, run by The Medical Research Network at 1 site in United States.
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 10 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 24 Aug 2016. 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 United States. 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?
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 of Improvement (CGI-I) Responder Rate (time frame: 12 weeks). 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 24 Aug 2016.