Clinical trial NCT01948895: Desvenlafaxine Monotherapy in Dysthymia
Official title: An 8-week Open-Label Flexible-Dose Study Of Desvenlafaxine as Monotherapy In The Treatment Of Dysthymia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysthymic Disorder
Keywords: Desvenlafaxine
Open-label
Flexible-dose
Dysthymic disorder
Anxiety disorders
Generalized anxiety disorder
Social anxiety disorder
Post-traumatic stress disorder
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2013-09-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale
timeFrame: 8 Weeks
Secondary outcomes:
measure: Clinical Global Impression Scale
timeFrame: 8 Weeks
measure: Health and Work Performance Questionnaire
timeFrame: Baseline, Week 8
measure: Perceived Stress Scale
timeFrame: Baseline, Week 8
measure: Quality of Life Enjoyment and Satisfaction Scale Quality of Life Enjoyment and Satisfaction Scale Quality of Life Enjoyment and Satisfaction Questionnaire
timeFrame: Baseline, Week 4, Week 8
measure: Quick Inventory of Depressive Symptomatology
timeFrame: Baseline, Week 4, Week 8
measure: Survey of Coping Profiles Endorsed
timeFrame: Baseline, Week 4, Week 8
measure: Sheehan Disability Scale
timeFrame: Baseline, Week 4, Week 8
measure: Work Productivity and Activity Impairment Questionnaire
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Medical Research Associates
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Arun Ravindran, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: