Dysthymic DisorderPhase 4NCT01537068
Desvenlafaxine vs. Placebo Treatment of Chronic Depression
A Phase 4 study testing Desvenlafaxine in people with Dysthymic Disorder and Dysthymia, run by New York State Psychiatric Institute at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Dysthymic Disorder, Dysthymia, Chronic Depressive Disorder
- What is being tested?
- Desvenlafaxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2012to Dec 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York State Psychiatric Institute/3 Columbus Circle Midtown
New York, New York, 10019
Depression Evaluation Service (DES), New York State Psychiatric Institute, Columbia University Department of Psychiatry
New York, New York, 10032
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Dysthymic Disorder, Dysthymia, Chronic Depressive Disorder
- Being tested
- Desvenlafaxine, Placebo
- Keywords
- Dysthymic disorder, Dysthymia, Chronic non-major depression, Non-major chronic depression, Chronic depressive disorder, Antidepressant treatment
- Medical subject headings
- Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesvenlafaxineDrug
Also called Pristiq
Desvenlafaxine oral dose ranging from 50 to 100 mg/day
PlaceboDrug
Also called Inactive comparator
Matching placebo pills
| Study group | Role | What they receive |
|---|---|---|
| Desvenlafaxine | Experimental | Serotonin-norepinephrine reuptake inhibitors (SNRIs) antidepressant drug Receives: Drug: Desvenlafaxine |
| Placebo | Placebo comparator | Placebo treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression (HDRS24)
HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression
Measured: Baseline
Hamilton Rating Scale for Depression (HDRS24)
HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression
Measured: Week 12
Secondary outcomes (1)
Response Rate
Assessment of overall improvement: based on HDRS and Clinical Global Improvement Scale Response Rate is defined as 50% improvement of Hamd24 summary scores from baseline.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dysthymic DisorderStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- David J Hellerstein, MD, Principal investigator, New York State Psychiatric Institute, Columbia University Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537068
- Sponsor's protocol ID
- #6457 Pfizer-WS1895577
- Status last verified
- Sep 2017
- First submitted
- 16 Feb 2012
- Last updated
- 11 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
DeMartinis NA, Yeung PP, Entsuah R, Manley AL. A double-blind, placebo-controlled study of the efficacy and safety of desvenlafaxine succinate in the treatment of major depressive disorder. J Clin Psychiatry. 2007 May;68(5):677-88. doi: 10.4088/jcp.v68n0504.
PubMed 17503976Levkovitz Y, Tedeschini E, Papakostas GI. Efficacy of antidepressants for dysthymia: a meta-analysis of placebo-controlled randomized trials. J Clin Psychiatry. 2011 Apr;72(4):509-14. doi: 10.4088/JCP.09m05949blu.
PubMed 21527126Bansal R, Hellerstein DJ, Sawardekar S, Chen Y, Peterson BS. Effects of antidepressant medications on brain tissue microstructure in persistent depressive disorder across two randomized controlled trials. Neuroimage Clin. 2026;50:104013. doi: 10.1016/j.nicl.2026.104013. Epub 2026 May 27.
PubMed 42214294Bansal R, Hellerstein DJ, Sawardekar S, Chen Y, Peterson BS. A randomized controlled trial of desvenlafaxine-induced structural brain changes in the treatment of persistent depressive disorder. Psychiatry Res Neuroimaging. 2023 Jun;331:111634. doi: 10.1016/j.pscychresns.2023.111634. Epub 2023 Mar 24.
PubMed 36996664Yang J, Hellerstein DJ, Chen Y, McGrath PJ, Stewart JW, Peterson BS, Wang Z. Serotonin-norepinephrine reuptake inhibitor antidepressant effects on regional connectivity of the thalamus in persistent depressive disorder: evidence from two randomized, double-blind, placebo-controlled clinical trials. Brain Commun. 2022 Apr 15;4(3):fcac100. doi: 10.1093/braincomms/fcac100. eCollection 2022.
PubMed 35592490Hellerstein DJ, Stewart JW, Chen Y, Arunagiri V, Peterson BS, McGrath PJ. Desvenlafaxine vs. placebo in the treatment of persistent depressive disorder. J Affect Disord. 2019 Feb 15;245:403-411. doi: 10.1016/j.jad.2018.11.065. Epub 2018 Nov 5.
PubMed 30423468
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desvenlafaxine (Pristiq) vs. Placebo in the Treatment of Chronic Depression
- ClinicalTrials.gov ID
- NCT01537068
- Acronym / sponsor ID
- #6457 Pfizer-WS1895577
- Conditions
- Dysthymic Disorder, Dysthymia, Chronic Depressive Disorder
- Keywords
- Dysthymic disorder, Dysthymia, Chronic non-major depression, Non-major chronic depression, Chronic depressive disorder, Antidepressant treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2012 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Feb 2012 (estimated)
- Results
- Posted 11 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desvenlafaxine | Experimental | Drug: DesvenlafaxineSerotonin-norepinephrine reuptake inhibitors (SNRIs) antidepressant drug |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo treatment |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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: PristiqDesvenlafaxine oral dose ranging from 50 to 100 mg/day | Drug | Desvenlafaxine |
| PlaceboAlso: Inactive comparatorMatching placebo pills | Drug | Placebo |
Primary outcome
Hamilton Rating Scale for Depression (HDRS24)
Time frame: Baseline
HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression
Hamilton Rating Scale for Depression (HDRS24)
Time frame: Week 12
HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression
1 secondary outcome
Response Rate
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17503976DeMartinis NA, Yeung PP, Entsuah R, Manley AL. A double-blind, placebo-controlled study of the efficacy and safety of desvenlafaxine succinate in the treatment of major depressive disorder. J Clin Psychiatry. 2007 May;68(5):677-88. doi: 10.4088/jcp.v68n0504.
- Background: PubMed 21527126Levkovitz Y, Tedeschini E, Papakostas GI. Efficacy of antidepressants for dysthymia: a meta-analysis of placebo-controlled randomized trials. J Clin Psychiatry. 2011 Apr;72(4):509-14. doi: 10.4088/JCP.09m05949blu.
- Derived from this study: PubMed 42214294Bansal R, Hellerstein DJ, Sawardekar S, Chen Y, Peterson BS. Effects of antidepressant medications on brain tissue microstructure in persistent depressive disorder across two randomized controlled trials. Neuroimage Clin. 2026;50:104013. doi: 10.1016/j.nicl.2026.104013. Epub 2026 May 27.
- Derived from this study: PubMed 36996664Bansal R, Hellerstein DJ, Sawardekar S, Chen Y, Peterson BS. A randomized controlled trial of desvenlafaxine-induced structural brain changes in the treatment of persistent depressive disorder. Psychiatry Res Neuroimaging. 2023 Jun;331:111634. doi: 10.1016/j.pscychresns.2023.111634. Epub 2023 Mar 24.
- Derived from this study: PubMed 35592490Yang J, Hellerstein DJ, Chen Y, McGrath PJ, Stewart JW, Peterson BS, Wang Z. Serotonin-norepinephrine reuptake inhibitor antidepressant effects on regional connectivity of the thalamus in persistent depressive disorder: evidence from two randomized, double-blind, placebo-controlled clinical trials. Brain Commun. 2022 Apr 15;4(3):fcac100. doi: 10.1093/braincomms/fcac100. eCollection 2022.
- Derived from this study: PubMed 30423468Hellerstein DJ, Stewart JW, Chen Y, Arunagiri V, Peterson BS, McGrath PJ. Desvenlafaxine vs. placebo in the treatment of persistent depressive disorder. J Affect Disord. 2019 Feb 15;245:403-411. doi: 10.1016/j.jad.2018.11.065. Epub 2018 Nov 5.
- Depression Evaluation Service, NY State Psychiatric Institute websiteLink provided by the sponsor.
- Columbia Psychiatry website, clinical trialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
David J Hellerstein, MD principal investigator
New York State Psychiatric Institute, Columbia University Department of Psychiatry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desvenlafaxine in people with Dysthymic Disorder and Dysthymia, run by New York State Psychiatric Institute at 2 sites in United States.
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 4 inclusion and 8 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 11 Sep 2017. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hamilton Rating Scale for Depression (HDRS24) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01537068, which also lists 6 linked publications.
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 11 Sep 2017.