Generalized Anxiety DisorderPhase 4NCT01975480
Efficacy of SNRI Treatment on Prefrontality in Patients With GAD and Other Comorbities
A Phase 4 study testing Desvenlafaxine in people with Generalized Anxiety Disorder, run by START Clinic for Mood and Anxiety Disorders at 1 site in Canada.
Trial summary
This is an open-label flexible-dose pilot study evaluating the efficacy, safety, and tolerability of Pristiq (desvenlafaxine) in outpatient subjects diagnosed with Generalized Anxiety Disorder (GAD) with or without comorbidities that are secondary to the GAD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Desvenlafaxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to 1 May 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has provided signed informed consent.
- Outpatients aged 18-65 (extremes included).
- Patients with a primary diagnosis of GAD according to DSM IV (300.23) criteria (diagnosis to be made using the Mini International Neuropsychiatric Interview; MINI Version 6.0.0). Patients with co-morbid anxiety disorders will be permitted, as long as GAD is judged to be the primary diagnosis.
- Patients who score a HAM-A of ≥ 20 at both Screening and Baseline, and ≥ 10 on the psychic and somatic anxiety factors.
- On the basis of physical examination, medical history, and basic laboratory screening, patient is, in the investigator's opinion, in a suitable condition.
- Willing and able to attend study appointments in the correct time windows.
Who cannot join
- Any other axis I diagnosis that was a primary disorder in the previous six months.
- Alcohol or drug abuse as defined in the DSM IV (300.23) within the last six months.
- Mania, hypomania as defined in the DSM IV (300.23).
- Any psychotic disorder.
- Eating disorders as defined in the DSM IV (300.23).
- Any cognitive disorder or dementia within 3 months before the baseline visit.
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- Clinical interpretation of apparent suicide risk.
- Continuation or commencement of formal psychotherapy.
- Current use of or commencement of antidepressant and anxiolytic medications.
- Failure on no more than 2 antidepressants (either SSRIs or SNRIs to exclude any treatment resistance.
- 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 a herbal or alternative treatment judged to be potentially anxiolytic or with psychobiological activity (e.g. St. John's Wort, S-adenosylmethionine), will have terminated usage of the agent more than two weeks prior to entering the study.
- Scores on the Hamilton Depression Rating Scale (HAM-D) > 15, at screening visit 1
- Laboratory values at screening or in medical history that may be considered through clinical interpretation to be significant.
- Diseases that could through clinical interpretation interfere with the assessments of safety, tolerability and efficacy.
- Serious illness: Liver or renal insufficiency, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic or metabolic disturbance.
- If female, the subject is pregnant or lactating or intending to become pregnant before, during or within 30 days after participating in this study; or intending to donate ova during such time period.
- The subject has received electroconvulsive therapy, vagal nerve stimulation, or repetitive transcranial magnetic stimulation within 6 months prior to Screening.
- The patient is, in the opinion of the investigator, unlikely to comply with the clinical trial protocol or is unsuitable for any reason.
- Known allergy or intolerance to desvenlafaxine or its excipients.
Trial locations and contacts
1 site in 1 country.
Canada1 site
START Clinic for Mood and Anxiety Disorders
Toronto, Ontario, M4W 2N4
About this study
Official title: Efficacy of Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) Treatment on Prefrontality in Patients With Generalized Anxiety Disorder (GAD) and Other Comorbidities
This is an open-label flexible-dose pilot study evaluating the efficacy, safety, and tolerability of Pristiq (desvenlafaxine) in outpatient subjects diagnosed with Generalized Anxiety Disorder (GAD) with or without comorbidities that are secondary to the GAD. Primary trial objective is to evaluate the efficacy of Pristiq (desvenlafaxine) SNRI treatment 50 to 100 mg once daily in the treatment of GAD with or without comorbidities. Secondary trial objective is to determine whether or not treatment outcome in GAD is related to changes in cortical prefrontal activity of norepinephrine.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Desvenlafaxine
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesvenlafaxineDrug
Also called Pristiq
| Study group | Role | What they receive |
|---|---|---|
| Desvenlafaxine | Experimental | At the screening visit those who are eligible will enter a randomized trial with Pristiq (desvenlafaxine) 50 to 100 mg. The study will begin with a single week of Pristiq (desvenlafaxine) 50mg. Subsequently, tablets will be administered in a flexible dose fashion and patients will be followed up weekly (biweekly after week 8) and at the investigators discretion. After the first week the patients' dosage will be increased up to a maximum of 100 mg daily. This dose will remain fixed after 8 weeks of treatment until week 16. Receives: Drug: Desvenlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean changes in the Hamilton Anxiety Rating Scale from baseline visit to week 16.
Measured: 16 weeks
Secondary outcomes (1)
Mean change from baseline to week 16 on the measures of prefrontality including: Frontal System Behavioural Scale and Behaviour Rating Inventory of Executive Function-Adult
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 posted4 Nov 2013 (estimated)
- Study startJan 2013
- Primary completion15 Apr 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- START Clinic for Mood and Anxiety Disorders
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Martin A. Katzman, START Clinic for Mood and Anxiety Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975480
- Sponsor's protocol ID
- WS2382578
- Status last verified
- Oct 2020
- First submitted
- 23 Oct 2013
- Last updated
- 23 Oct 2020
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) Treatment on Prefrontality in Patients With Generalized Anxiety Disorder (GAD) and Other Comorbidities
- ClinicalTrials.gov ID
- NCT01975480
- Acronym / sponsor ID
- WS2382578
- Conditions
- Generalized Anxiety Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- START Clinic for Mood and Anxiety DisordersUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 4 Nov 2013 (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 is an open-label flexible-dose pilot study evaluating the efficacy, safety, and tolerability of Pristiq (desvenlafaxine) in outpatient subjects diagnosed with Generalized Anxiety Disorder (GAD) with or without comorbidities that are secondary to the GAD. Primary trial objective is to evaluate the efficacy of Pristiq (desvenlafaxine) SNRI treatment 50 to 100 mg once daily in the treatment of GAD with or without comorbidities. Secondary trial objective is to determine whether or not treatment outcome in GAD is related to changes in cortical prefrontal activity of norepinephrine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desvenlafaxine | Experimental | Drug: DesvenlafaxineAt the screening visit those who are eligible will enter a randomized trial with Pristiq (desvenlafaxine) 50 to 100 mg. The study will begin with a single week of Pristiq (desvenlafaxine) 50mg. Subsequently, tablets will be administered in a flexible dose fashion and patients will be followed up weekly (biweekly after week 8) and at the investigators discretion. After the first week the patients' dosage will be increased up to a maximum of 100 mg daily. This dose will remain fixed after 8 weeks of treatment until week 16. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient has provided signed informed consent.
- Outpatients aged 18-65 (extremes included).
- Patients with a primary diagnosis of GAD according to DSM IV (300.23) criteria (diagnosis to be made using the Mini International Neuropsychiatric Interview; MINI Version 6.0.0). Patients with co-morbid anxiety disorders will be permitted, as long as GAD is judged to be the primary diagnosis.
- Patients who score a HAM-A of ≥ 20 at both Screening and Baseline, and ≥ 10 on the psychic and somatic anxiety factors.
- On the basis of physical examination, medical history, and basic laboratory screening, patient is, in the investigator's opinion, in a suitable condition.
Key exclusion criteria (20 listed)
- Any other axis I diagnosis that was a primary disorder in the previous six months.
- Alcohol or drug abuse as defined in the DSM IV (300.23) within the last six months.
- Mania, hypomania as defined in the DSM IV (300.23).
- Any psychotic disorder.
- Eating disorders as defined in the DSM IV (300.23).
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 |
|---|---|---|
| DesvenlafaxineAlso: Pristiq | Drug | Desvenlafaxine |
Primary outcome
Mean changes in the Hamilton Anxiety Rating Scale from baseline visit to week 16.
Time frame: 16 weeks
1 secondary outcome
Mean change from baseline to week 16 on the measures of prefrontality including: Frontal System Behavioural Scale and Behaviour Rating Inventory of Executive Function-Adult
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Desvenlafaxine in people with Generalized Anxiety Disorder, run by START Clinic for Mood and Anxiety Disorders 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 6 inclusion and 20 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: finished, as of the sponsor's last update on 23 Oct 2020. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean changes in the Hamilton Anxiety Rating Scale from baseline visit to week 16. (time frame: 16 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 23 Oct 2020.