Recruitment

Recruitment Status
Completed

Inclusion Criterias

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

Exclusion Criterias

Have received physical therapies for depression (e.g. ECT, rTMS) within the 3 months prior to randomization.
Psychotropics such as other SSRIs, other SNRIs, lithium, sibutramine, tramadol, St. John's Wort, within 2 weeks of randomization
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.
Psychotropics such as other SSRIs, other SNRIs, lithium, sibutramine, tramadol, St. John's Wort, within 2 weeks of randomization
Agents that impact significantly on serotonin metabolism (e.g. MAOIs, tryptophan, triptans) within 2 weeks of randomization
Substance abuse or dependence including alcohol, within 6 months prior to screening.
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).
Clinically significant abnormalities in hematology, clinical chemistry, urinalysis or ECG at the screening visit, as judged by the Principal Investigator.
Previous non-response to a therapeutic trial of desvenlafaxine (at least 50 mg/day for 2 months).
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.
Presence of medical or psychiatric condition deemed by the Investigator to interfere with study procedures or endpoint data.

Summary

Conditions
Dysthymic Disorder
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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 occupatio...

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.

Inclusion Criterias

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

Exclusion Criterias

Have received physical therapies for depression (e.g. ECT, rTMS) within the 3 months prior to randomization.
Psychotropics such as other SSRIs, other SNRIs, lithium, sibutramine, tramadol, St. John's Wort, within 2 weeks of randomization
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.
Psychotropics such as other SSRIs, other SNRIs, lithium, sibutramine, tramadol, St. John's Wort, within 2 weeks of randomization
Agents that impact significantly on serotonin metabolism (e.g. MAOIs, tryptophan, triptans) within 2 weeks of randomization
Substance abuse or dependence including alcohol, within 6 months prior to screening.
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).
Clinically significant abnormalities in hematology, clinical chemistry, urinalysis or ECG at the screening visit, as judged by the Principal Investigator.
Previous non-response to a therapeutic trial of desvenlafaxine (at least 50 mg/day for 2 months).
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.
Presence of medical or psychiatric condition deemed by the Investigator to interfere with study procedures or endpoint data.

Locations

Toronto, Ontario, M5T 1R8
Mississauga, Ontario, L5M 4N4
Toronto, Ontario, M5T 1R8
Mississauga, Ontario, L5M 4N4

Tracking Information

NCT #
NCT01948895
Collaborators
Not Provided
Investigators
  • Principal Investigator: Arun Ravindran, MD, PhD Centre for Addiction and Mental Health
  • Arun Ravindran, MD, PhD Centre for Addiction and Mental Health