- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01975480
Efficacy of SNRI Treatment on Prefrontality in Patients With GAD and Other Comorbities
October 21, 2020 updated by: Dr. Martin A. Katzman, START Clinic for Mood and Anxiety Disorders
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4W 2N4
- START Clinic for Mood and Anxiety Disorders
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Desvenlafaxine
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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean changes in the Hamilton Anxiety Rating Scale from baseline visit to week 16.
Time Frame: 16 weeks
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16 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
April 15, 2020
Study Completion (Actual)
May 1, 2020
Study Registration Dates
First Submitted
October 23, 2013
First Submitted That Met QC Criteria
October 28, 2013
First Posted (Estimate)
November 3, 2013
Study Record Updates
Last Update Posted (Actual)
October 23, 2020
Last Update Submitted That Met QC Criteria
October 21, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Anxiety Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Desvenlafaxine Succinate
Other Study ID Numbers
- WS2382578
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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