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Trial record 3 of 123 for:    Dysthymia
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Desvenlafaxine Monotherapy in Dysthymia

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ClinicalTrials.gov Identifier: NCT01948895
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : November 7, 2014
Sponsor:
Information provided by (Responsible Party):
Arun Ravindran, Centre for Addiction and Mental Health

Study Description
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Brief Summary:
This multi-centred study will be conducted at two centres. The design will be an open label, flexible-dose study. This investigation will evaluate the efficacy of Desvenlafaxine monotherapy for patients who meet diagnostic criteria for dysthymia.

Condition or disease Intervention/treatment Phase
Dysthymic Disorder Drug: Desvenlafaxine Not Applicable

Detailed Description:

Primary objective: To investigate the efficacy, safety, and tolerability of open-label desvenlafaxine monotherapy in dysthymic subjects.

Secondary objectives: To evaluate the efficacy of desvenlafaxine on clinical measures relating to improvement of depressive symptoms, quality of life and occupational functioning.

It is hypothesized that Dysthymic subjects will show significant improvement in depressive symptoms after 8 weeks of treatment with desvenlafaxine. There will be significant improvement in measures of quality of life and stress coping at end of treatment, compared to Baseline. There will also be significant improvement in measures of occupational functioning at end of treatment, compared to Baseline.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An 8-week Open-Label Flexible-Dose Study Of Desvenlafaxine as Monotherapy In The Treatment Of Dysthymia
Study Start Date : August 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Single-arm study
Desvenlafaxine 50mg/day Desvenlafaxine 100mg/day
 Drug: Desvenlafaxine
Patients will be initiated on 50 mg/day of Desvenlafaxine. No dose changes will be allowed for the first four weeks. If there is partial or no response after four weeks, dosage will then be increased to 100mg/day, based on tolerability and the Investigator's judgment.
Other Name: Pristiq


Outcome Measures
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Primary Outcome Measures :
  1. Montgomery-Åsberg Depression Rating Scale [ Time Frame: 8 Weeks ]

Secondary Outcome Measures :
  1. Clinical Global Impression Scale [ Time Frame: 8 Weeks ]
  2. Health and Work Performance Questionnaire [ Time Frame: Baseline, Week 8 ]
  3. Perceived Stress Scale [ Time Frame: Baseline, Week 8 ]
  4. Quality of Life Enjoyment and Satisfaction Scale Quality of Life Enjoyment and Satisfaction Scale Quality of Life Enjoyment and Satisfaction Questionnaire [ Time Frame: Baseline, Week 4, Week 8 ]
  5. Quick Inventory of Depressive Symptomatology [ Time Frame: Baseline, Week 4, Week 8 ]
  6. Survey of Coping Profiles Endorsed [ Time Frame: Baseline, Week 4, Week 8 ]
  7. Sheehan Disability Scale [ Time Frame: Baseline, Week 4, Week 8 ]
  8. Work Productivity and Activity Impairment Questionnaire [ Time Frame: Baseline, Week 8 ]

Eligibility Criteria
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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:

  • Male and female patients between 18-65 years.
  • Primary diagnosis of Dysthymic Disorder, as defined by DSM-IV criteria (300.4).
  • MADRS score ≥15 at Screening and Baseline.
  • Supportive therapy, and use of zopiclone for sleep and low-dose benzodiazepines on an as needed basis for anxiety, is allowed at any time.
  • Written informed consent

Exclusion Criteria:

  • Co-morbid diagnosis of any other Axis I disorders (other than anxiety disorders such as Generalized Anxiety Disorder, Social Anxiety Disorder and Post-traumatic Stress Disorder, provided that Dysthymic Disorder is currently the diagnosis).
  • Meet DSM-IV criteria for a current episode of major depression within two months prior to screening or who have received treatment for a major depressive episode within six months prior to screening.
  • Substance abuse or dependence including alcohol, within 6 months prior to screening.

  • Patients on the following prohibited treatments:

    1. Psychotropics such as other SSRIs, other SNRIs, lithium, sibutramine, tramadol, St. John's Wort, within 2 weeks of randomization
    2. Agents that impact significantly on serotonin metabolism (e.g. MAOIs, tryptophan, triptans) within 2 weeks of randomization
  • Have received physical therapies for depression (e.g. ECT, rTMS) within the 3 months prior to randomization.
  • Previous non-response to a therapeutic trial of desvenlafaxine (at least 50 mg/day for 2 months).
  • Clinically significant abnormalities in hematology, clinical chemistry, urinalysis or ECG at the screening visit, as judged by the Principal Investigator.
  • Presence of medical or psychiatric condition deemed by the Investigator to interfere with study procedures or endpoint data.
Contacts and Locations
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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): NCT01948895


Locations
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Canada, Ontario
Medical Research Associates
Mississauga, Ontario, Canada, L5M 4N4
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: Arun Ravindran, MD, PhD Centre for Addiction and Mental Health
More Information
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Additional Information:

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Responsible Party: Arun Ravindran, Principal Investigator, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01948895    
Other Study ID Numbers: 124/2012
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: November 7, 2014
Last Verified: November 2014
Keywords provided by Arun Ravindran, Centre for Addiction and Mental Health:
Desvenlafaxine
Open-label
Flexible-dose
Dysthymic disorder
 Anxiety disorders
Generalized anxiety disorder
Social anxiety disorder
Post-traumatic stress disorder
Additional relevant MeSH terms:
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Dysthymic Disorder
Depressive Disorder
Mood Disorders
Mental Disorders
Desvenlafaxine Succinate
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