Dysthymic DisorderNCT01948895
Desvenlafaxine Monotherapy in Dysthymia
A study testing Desvenlafaxine in people with Dysthymic Disorder, run by Centre for Addiction and Mental Health at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dysthymic Disorder
- What is being tested?
- Desvenlafaxine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Medical Research Associates
Mississauga, Ontario, L5M 4N4
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8
About this study
Official title: An 8-week Open-Label Flexible-Dose Study Of Desvenlafaxine as Monotherapy In The Treatment Of Dysthymia
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.
Read the 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.
- Conditions
- Dysthymic Disorder
- Being tested
- Desvenlafaxine
- Keywords
- Desvenlafaxine, Open-label, Flexible-dose, Dysthymic disorder, Anxiety disorders, Generalized anxiety disorder, Social anxiety disorder, Post-traumatic stress disorder
- Medical subject headings
- Dysthymic Disorder, Anxiety Disorders, Generalized Anxiety Disorder, Phobia, Social, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesvenlafaxineDrug
Also called Pristiq
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm study | Experimental | Desvenlafaxine 50mg/day Desvenlafaxine 100mg/day Receives: Drug: Desvenlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale
Measured: 8 Weeks
Secondary outcomes (8)
Clinical Global Impression Scale
Measured: 8 Weeks
Health and Work Performance Questionnaire
Measured: Baseline, Week 8
Perceived Stress Scale
Measured: Baseline, Week 8
Quality of Life Enjoyment and Satisfaction Scale Quality of Life Enjoyment and Satisfaction Scale Quality of Life Enjoyment and Satisfaction Questionnaire
Measured: Baseline, Week 4, Week 8
Quick Inventory of Depressive Symptomatology
Measured: Baseline, Week 4, Week 8
Survey of Coping Profiles Endorsed
Measured: Baseline, Week 4, Week 8
Sheehan Disability Scale
Measured: Baseline, Week 4, Week 8
Work Productivity and Activity Impairment Questionnaire
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startAug 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysthymic DisorderStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arun Ravindran, Centre for Addiction and Mental Health
- Investigators
- Arun Ravindran, MD, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948895
- Sponsor's protocol ID
- 124/2012
- Status last verified
- Nov 2014
- First submitted
- 19 Sep 2013
- Last updated
- 7 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-week Open-Label Flexible-Dose Study Of Desvenlafaxine as Monotherapy In The Treatment Of Dysthymia
- ClinicalTrials.gov ID
- NCT01948895
- Acronym / sponsor ID
- 124/2012
- Conditions
- Dysthymic Disorder
- Keywords
- Desvenlafaxine, Open-label, Flexible-dose, Dysthymic disorder, Anxiety disorders, Generalized anxiety disorder, Social anxiety disorder, Post-traumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 24 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm study | Experimental | Drug: DesvenlafaxineDesvenlafaxine 50mg/day Desvenlafaxine 100mg/day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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:
- Have received physical therapies for depression (e.g. ECT, rTMS) within the 3 months prior to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesvenlafaxineAlso: PristiqPatients 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. | Drug | Single-arm study |
Primary outcome
Montgomery-Åsberg Depression Rating Scale
Time frame: 8 Weeks
8 secondary outcomes
Clinical Global Impression Scale
Time frame: 8 Weeks
Health and Work Performance Questionnaire
Time frame: Baseline, Week 8
Perceived Stress Scale
Time frame: Baseline, Week 8
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
Quick Inventory of Depressive Symptomatology
Time frame: Baseline, Week 4, Week 8
Survey of Coping Profiles Endorsed
Time frame: Baseline, Week 4, Week 8
Sheehan Disability Scale
Time frame: Baseline, Week 4, Week 8
Work Productivity and Activity Impairment Questionnaire
Time frame: Baseline, Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2014.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
Related trials for Dysthymic Disorder
Recruiting
Mindful Self-compassion for Anxiety and Depression: Impact of Delivery Method
Anxiety Disorders, Generalized Anxiety Disorder
Active, not recruiting
Clinical Effectiveness of TARA Compared to Standard Treatment for Adolescents and Young Adults With Depression
Depression in Adolescence, Depressive Disorder
Recruiting
Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression
Anxiety Disorders, Depressive Disorder
Active, not recruitingObservational study
Characterizing MyMood Patterns of Use
Bipolar Disorder, Mood Disorders
Not yet recruiting
Testing a Precision Psychotherapy System for Low-income Patients
Major Depressive Disorder, Dysthymic Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun Ravindran, MD, PhD principal investigator
Centre for Addiction and Mental Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desvenlafaxine in people with Dysthymic Disorder, run by Centre for Addiction and Mental Health at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Åsberg Depression Rating Scale (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2014.