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Trial record 25 of 89 for:    DESVENLAFAXINE

Efficacy of SNRI Treatment on Prefrontality in Patients With GAD and Other Comorbities

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ClinicalTrials.gov Identifier: NCT01975480
Recruitment Status : Recruiting
First Posted : November 4, 2013
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Martin A. Katzman, START Clinic for Mood and Anxiety Disorders

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Drug: Desvenlafaxine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label.
Primary Purpose: Treatment
Official Title: Efficacy of Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) Treatment on Prefrontality in Patients With Generalized Anxiety Disorder (GAD) and Other Comorbidities
Study Start Date : January 2013
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.
Drug: Desvenlafaxine
Other Name: Pristiq




Primary Outcome Measures :
  1. Mean changes in the Hamilton Anxiety Rating Scale from baseline visit to week 16. [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  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 [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975480


Contacts
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Contact: Martin A Katzman, BSc, MD, FRCPC 416-598-9344 mkatzman@startclinic.ca

Locations
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Canada, Ontario
START Clinic for Mood and Anxiety Disorders Recruiting
Toronto, Ontario, Canada, M4W 2N4
Contact: Martin A Katzman, BSc, MD, FRCPC    416-598-9344    mkatzman@startclinic.ca   
Principal Investigator: Martin A Katzman, BSc         
Sponsors and Collaborators
START Clinic for Mood and Anxiety Disorders

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Responsible Party: Dr. Martin A. Katzman, Principal Investigator, START Clinic for Mood and Anxiety Disorders
ClinicalTrials.gov Identifier: NCT01975480     History of Changes
Other Study ID Numbers: WS2382578
First Posted: November 4, 2013    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Desvenlafaxine Succinate
Anxiety Disorders
Mental Disorders
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs