Desvenlafaxine vs. Placebo Treatment of Chronic Depression
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Endocrine |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 20 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | February 2012 |
| End Date: | June 2016 |
| Contact: | Donna O'Shea, BS |
| Email: | osheado@nyspi.columbia.edu |
| Phone: | 646-774-7946 |
Desvenlafaxine (Pristiq) vs. Placebo in the Treatment of Chronic Depression
The investigators are studying a new antidepressant medicine, desvenlafaxine, for the
treatment of people with chronic depression. Desvenlafaxine (trade name Pristiq) has been
approved by the FDA for the treatment of major depression.
The investigators are testing whether this medicine is also effective for adults with a type
of chronic depression that is less severe than major depression. This condition is also
known as dysthymic disorder or dysthymia. Chronic depression, lasting two or more years,
often causes significant suffering and impairment.
In addition, the investigators are using MRI imaging, which uses magnetic signals to make
pictures of the brain's structure and also of its functioning. The purpose of MRI imaging in
this study is to see whether chronic depression is associated with differences in brain
structure or functioning, and whether such differences change after medication or placebo
treatment. To test this MRI scans are done at the start of the study and after 12 weeks of
medication or placebo treatment. Getting MRI imaging will be an option for participants in
this study but is not required.
This study involves a 6 to 12 week double-blind period during which half of the participants
will take the new medication and half will take a placebo (an inactive look-alike pill).
After the double blind phase, all subjects can be treated for 12 weeks with an FDA-approved
antidepressant medication.
Assessments (of depressive symptoms, social functioning, and personality) will be done by
study staff and by patients before the study starts, at each study visit for the first 12
weeks, and again after 24 weeks in the study.
treatment of people with chronic depression. Desvenlafaxine (trade name Pristiq) has been
approved by the FDA for the treatment of major depression.
The investigators are testing whether this medicine is also effective for adults with a type
of chronic depression that is less severe than major depression. This condition is also
known as dysthymic disorder or dysthymia. Chronic depression, lasting two or more years,
often causes significant suffering and impairment.
In addition, the investigators are using MRI imaging, which uses magnetic signals to make
pictures of the brain's structure and also of its functioning. The purpose of MRI imaging in
this study is to see whether chronic depression is associated with differences in brain
structure or functioning, and whether such differences change after medication or placebo
treatment. To test this MRI scans are done at the start of the study and after 12 weeks of
medication or placebo treatment. Getting MRI imaging will be an option for participants in
this study but is not required.
This study involves a 6 to 12 week double-blind period during which half of the participants
will take the new medication and half will take a placebo (an inactive look-alike pill).
After the double blind phase, all subjects can be treated for 12 weeks with an FDA-approved
antidepressant medication.
Assessments (of depressive symptoms, social functioning, and personality) will be done by
study staff and by patients before the study starts, at each study visit for the first 12
weeks, and again after 24 weeks in the study.
The investigators wish to study acute efficacy for 12 weeks on a double blind basis and
continued response after open-label treatment at week 24 follow-up. It is important to
establish the acute (12 week) efficacy of desvenlafaxine in non-major chronic depression.
Also, given that non-major chronic depression is by definition chronic, it is important to
demonstrate that benefit persists at follow-up assessment (24 weeks); this is clinically
important in trying to alleviate the significant psychosocial morbidity associated with this
disorder.
The investigators believe this study will have significant value in the treatment of
patients with non-major chronic depression, and will add significantly to what remains an
extremely small scientific literature.
The investigators would also like to study the effects of desvenlafaxine on brain structure
and function. Learning that a medication reduces symptoms does not teach us how the
medication achieves this outcome. Participants in this study can have the opportunity to
participate in MRI scanning that will help to understand the mechanisms by with
desvenlafaxine is effective. MRI scans are done prior to starting the clinical trial and
then again after completing the double blind clinical trial.
continued response after open-label treatment at week 24 follow-up. It is important to
establish the acute (12 week) efficacy of desvenlafaxine in non-major chronic depression.
Also, given that non-major chronic depression is by definition chronic, it is important to
demonstrate that benefit persists at follow-up assessment (24 weeks); this is clinically
important in trying to alleviate the significant psychosocial morbidity associated with this
disorder.
The investigators believe this study will have significant value in the treatment of
patients with non-major chronic depression, and will add significantly to what remains an
extremely small scientific literature.
The investigators would also like to study the effects of desvenlafaxine on brain structure
and function. Learning that a medication reduces symptoms does not teach us how the
medication achieves this outcome. Participants in this study can have the opportunity to
participate in MRI scanning that will help to understand the mechanisms by with
desvenlafaxine is effective. MRI scans are done prior to starting the clinical trial and
then again after completing the double blind clinical trial.
Inclusion Criteria:
- Male and female outpatients 20 to 65 years of age, inclusive
- Principal DSM-5 diagnosis of unipolar non-major Chronic Depressive Disorder
(including Major Depression in partial remission, Major Depression, residual,
Dysthymic Disorder, or Depressive Disorder NOS)
- Minimum of 2 years duration of the current episode of depressive disorder.
- Score of 12 or higher on the Hamilton Depression Scale (24 items) at baseline
Exclusion Criteria:
- Full remission of depression in past 24 months
- Current major depression diagnosis, psychotic illness
- Current risk of suicide
- Drug or alcohol abuse/dependence in past 6 months
- Active medical illness
- Prior nonresponse to desvenlafaxine
- Medical illness contraindicating use of desvenlafaxine
- Current or planned pregnancy during study period
We found this trial at
2
sites
New York, New York 10032
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