NCT01948895

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 7, 2014

Status Verified

November 1, 2014

Enrollment Period

1.8 years

First QC Date

September 19, 2013

Last Update Submit

November 6, 2014

Conditions

Dysthymic Disorder

Keywords

DesvenlafaxineOpen-labelFlexible-doseDysthymic disorderAnxiety disordersGeneralized anxiety disorderSocial anxiety disorderPost-traumatic stress disorder

Outcome Measures

Primary Outcomes (1)

  • Montgomery-Åsberg Depression Rating Scale

    8 Weeks

Secondary Outcomes (8)

  • Clinical Global Impression Scale

    8 Weeks

  • Health and Work Performance Questionnaire

    Baseline, Week 8

  • Perceived Stress Scale

    Baseline, Week 8

  • Quality of Life Enjoyment and Satisfaction Scale Quality of Life Enjoyment and Satisfaction Scale Quality of Life Enjoyment and Satisfaction Questionnaire

    Baseline, Week 4, Week 8

  • Quick Inventory of Depressive Symptomatology

    Baseline, Week 4, Week 8

  • +3 more secondary outcomes

Study Arms (1)

Single-arm study

EXPERIMENTAL

Desvenlafaxine 50mg/day Desvenlafaxine 100mg/day

Drug: Desvenlafaxine

Interventions

DesvenlafaxineDRUG

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.

Also known as: Pristiq
Single-arm study

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical Research Associates

Mississauga, Ontario, L5M 4N4, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Links

MeSH Terms

Conditions

Dysthymic DisorderAnxiety DisordersGeneralized Anxiety DisorderPhobia, SocialStress Disorders, Post-Traumatic

Interventions

Desvenlafaxine Succinate

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersPhobic DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticLipids

Study Officials

  • Arun Ravindran, MD, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 19, 2013

First Posted

September 24, 2013

Study Start

August 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

November 7, 2014

Record last verified: 2014-11

Locations

CA(2)