Atypical DepressionPhase 4NCT00296699
A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression
A Phase 4 study testing Duloxetine in people with Atypical Depression, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This is a Pilot Study to get a first indication whether Duloxetine may be effective for depressed patients with Atypical Features. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atypical Depression
- What is being tested?
- Duloxetine
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jun 2007
- Phase
- Phase 4
- 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
- DSM-IV Major Depression or Dysthymia with Atypical Features
- Age 18-65
- Physically healthy
- HAMD(24) > 14
Who cannot join
- Prior experience with Duloxetine
- History of Psychosis or Bipolar Disorder, Borderline Personality Disorder
- Unstable medical disorder; any history of Epilepsy
- Currently taking medication that can interact with Duloxetine
- Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol)
- Serious suicidal ideation judged at least somewhat likely to be acted upon or require hospitalization
Show all 13Show fewer
- Current (past two weeks) use of psychoactive medication (four weeks for Fluoxetine)
- Pregnancy
- Currently breast feeding
- Fecund women failing to use acceptable birth control
- Refractory Depression (defined as failure to respond to one or more adequate trials of marketed antidepressants [i.e., >=2/3 PDR maximum dose for at least 4 weeks] during current episode)
- Serious suicidal ideation, recent (past six months) suicidal activity, any life-time history of serious suicide attempt (e.g., admitted to ICU, any duration of coma)
- Currently taking medication deemed effective
Trial locations and contacts
1 site in 1 country.
United States1 site
Depression Evaluation Service - New York State Psychiatric Institute
New York, New York, 10032
About this study
This is a Pilot Study to get a first indication whether Duloxetine may be effective for depressed patients with Atypical Features.
Read the detailed description
This Open Pilot Study will assess whether Duloxetine is effective for patients with Atypical Features. 20 patients having Major Depressive Disorder with Atypical Features or Dysthymic Disorder will receive Duloxetine in open fashion for 8 weeks. Dose will begin with 20 mg/d and increase to PDR maximal dose of 120 mg/d, if tolerated.
- Conditions
- Atypical Depression
- Being tested
- Duloxetine
- Keywords
- Atypical Depression, Major Depressive Disorder, Dysthymic Disorder, Atypical Features, Duloxetine
- Medical subject headings
- Depressive Disorder, Major, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta
Day 1-7: 20 mg/d; day 8-24: 30 mg/d; day 15-28: 60 mg/d; day 29-56: 120 mg/d.
- dose raises will occur only if pt. is tolerating the previous dose and not remitting.; dose may be lowered or increased in 30 mg increments if pt. has difficulty tolerating.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale (HAM-D)
Measured: 10 weeks
Secondary outcomes (5)
Atypical Depression Diagnostic Scale (ADDS)
Measured: 10 weeks
Beck Depression Inventory (BDI)
Measured: 10 weeks
Clinical Global Impression (CGI)
Measured: 10 weeks
Patient Global Impression (PGI)
Measured: 10 weeks
Inventory of Depressive Symptoms(IDS)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startMar 2005
- Primary completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atypical DepressionStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Investigators
- Jonathan W. Stewart, M.D., Principal investigator, New York State Psychiatric Institute - Columbia University Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296699
- Sponsor's protocol ID
- IRB4943
- Status last verified
- Jan 2008
- First submitted
- 23 Feb 2006
- Last updated
- 15 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression
- ClinicalTrials.gov ID
- NCT00296699
- Acronym / sponsor ID
- IRB4943
- Conditions
- Atypical Depression
- Keywords
- Atypical Depression, Major Depressive Disorder, Dysthymic Disorder, Atypical Features, Duloxetine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Mar 2005
- Primary completion
- Jun 2007 (actual)
- First posted
- 27 Feb 2006 (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 is a Pilot Study to get a first indication whether Duloxetine may be effective for depressed patients with Atypical Features.
Detailed description
This Open Pilot Study will assess whether Duloxetine is effective for patients with Atypical Features. 20 patients having Major Depressive Disorder with Atypical Features or Dysthymic Disorder will receive Duloxetine in open fashion for 8 weeks. Dose will begin with 20 mg/d and increase to PDR maximal dose of 120 mg/d, if tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- DSM-IV Major Depression or Dysthymia with Atypical Features
- Age 18-65
- Physically healthy
- HAMD(24) > 14
Key exclusion criteria (13 listed)
- Prior experience with Duloxetine
- History of Psychosis or Bipolar Disorder, Borderline Personality Disorder
- Unstable medical disorder; any history of Epilepsy
- Currently taking medication that can interact with Duloxetine
- Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol)
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 |
|---|---|---|
| DuloxetineAlso: CymbaltaDay 1-7: 20 mg/d; day 8-24: 30 mg/d; day 15-28: 60 mg/d; day 29-56: 120 mg/d. * dose raises will occur only if pt. is tolerating the previous dose and not remitting.; dose may be lowered or increased in 30 mg increments if pt. has difficulty tolerating. | Drug | – |
Primary outcome
Hamilton Depression Scale (HAM-D)
Time frame: 10 weeks
5 secondary outcomes
Atypical Depression Diagnostic Scale (ADDS)
Time frame: 10 weeks
Beck Depression Inventory (BDI)
Time frame: 10 weeks
Clinical Global Impression (CGI)
Time frame: 10 weeks
Patient Global Impression (PGI)
Time frame: 10 weeks
Inventory of Depressive Symptoms(IDS)
Time frame: 10 weeks
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 15 Jan 2008.
- Depression Evaluation Service - official websiteLink provided by the sponsor.
- New York State Psychiatric Institute - official websiteLink provided by the sponsor.
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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.
Jonathan W. Stewart, M.D. principal investigator
New York State Psychiatric Institute - Columbia University Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duloxetine in people with Atypical Depression, run by New York State Psychiatric Institute at 1 site 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 13 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 15 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
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?
Hamilton Depression Scale (HAM-D) (time frame: 10 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 15 Jan 2008.