Atypical DepressionPhase 2/3NCT00215176
Modafinil for Atypical Depression
A Phase 2/3 study testing modafinil in people with Atypical Depression, run by Duke University.
Trial summary
The purposes of the study are to: 1) evaluate the short-term efficacy and safety of modafinil in atypical depression; and 2) to evaluate the efficacy of modafinil in preventing relapse of atypical depression. The hypothesis is that modafinil is safe and effective in the treatment of atypical depression. 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?
- modafinil
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to Apr 2005
- Phase
- Phase 2/3
- 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
- adults 18-65 years of age
- DSM-IV criteria for major depressive episode with atypical features as assessed by the Atypical Depression Diagnostic Scale
- minimum score of 18 on the Hamilton Depression Scale (29-item version) at baseline
- baseline Clinical Global Impressions Severity score of 4 or more
- written informed consent
- negative serum pregnancy test for women of childbearing potential
Who cannot join
- any current primary DSM-IV Axis I disorder other than depression
- history of DSM-IV diagnosis of bipolar I disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition
- history of substance abuse or dependence within the last 3 months
- suicide risk or serious suicide attempt with the last year
- clinically significant medical condition or laboratory or EKG abnormality
- history of non-response to three prior adequate trials of antidepressants
Show all 10Show fewer
- women of childbearing potential who are unwilling to practice an acceptable method of contraception
- history of hypersensitivity to modafinil
- use of an investigational medication within the last 28 days
- use of antidepressant medication with 28 days of screening
About this study
Official title: A Study of Modafinil for Atypical Depression
The purposes of the study are to: 1) evaluate the short-term efficacy and safety of modafinil in atypical depression; and 2) to evaluate the efficacy of modafinil in preventing relapse of atypical depression. The hypothesis is that modafinil is safe and effective in the treatment of atypical depression.
Read the detailed description
This study on the safety and efficacy of modafinil on atypical depression has an initial 12-week open label treatment period with modafinil that is followed by a 12-week double-blind, randomized parallel treatment period with either modafinil or matching placebo. Patients who demonstrate at least minimal improvement after 12 weeks are randomly assigned to either continuing treatment at their current dose or switched to matching placebo for 12 weeks.
- Conditions
- Atypical Depression
- Being tested
- modafinil
- Keywords
- atypical depression, psychostimulants, modafinil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modafinilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HAM-D-29 (Hamilton Depression 29-Item Scale, with Atypical Features)
Secondary outcomes (8)
ADDS (Atypical Depression Diagnostic Scale)
CGI-S (Clinical Global Impressions Severity Scale)
CGI-I (Clinical Global Impressions Improvement Scale)
SCL-90 (Symptom Checklist 90)
ESS (Epworth Sleepiness Scale)
BFI (Brief Fatigue Inventory)
FSS (Fatigue Severity Scale)
SOS (Severity of Symptoms Scale)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startFeb 2003
- Study completionApr 2005
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.
- More trials run by Duke UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 65 participants
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon
- Investigators
- Jonathan Davidson, M.D., Principal investigator, Duke Univeristy Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215176
- Sponsor's protocol ID
- 4428
- Status last verified
- Sep 2005
- First submitted
- 20 Sep 2005
- Last updated
- 19 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Modafinil for Atypical Depression
- ClinicalTrials.gov ID
- NCT00215176
- Acronym / sponsor ID
- 4428
- Conditions
- Atypical Depression
- Keywords
- atypical depression, psychostimulants, modafinil
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Cephalon
- Study start
- Feb 2003
- Study completion
- Apr 2005
- First posted
- 22 Sep 2005 (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.
The purposes of the study are to: 1) evaluate the short-term efficacy and safety of modafinil in atypical depression; and 2) to evaluate the efficacy of modafinil in preventing relapse of atypical depression. The hypothesis is that modafinil is safe and effective in the treatment of atypical depression.
Detailed description
This study on the safety and efficacy of modafinil on atypical depression has an initial 12-week open label treatment period with modafinil that is followed by a 12-week double-blind, randomized parallel treatment period with either modafinil or matching placebo. Patients who demonstrate at least minimal improvement after 12 weeks are randomly assigned to either continuing treatment at their current dose or switched to matching placebo for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adults 18-65 years of age
- DSM-IV criteria for major depressive episode with atypical features as assessed by the Atypical Depression Diagnostic Scale
- minimum score of 18 on the Hamilton Depression Scale (29-item version) at baseline
- baseline Clinical Global Impressions Severity score of 4 or more
- written informed consent
Key exclusion criteria (10 listed)
- any current primary DSM-IV Axis I disorder other than depression
- history of DSM-IV diagnosis of bipolar I disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition
- history of substance abuse or dependence within the last 3 months
- suicide risk or serious suicide attempt with the last year
- clinically significant medical condition or laboratory or EKG abnormality
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 |
|---|---|---|
| modafinil | Drug | – |
Primary outcome
HAM-D-29 (Hamilton Depression 29-Item Scale, with Atypical Features)
8 secondary outcomes
ADDS (Atypical Depression Diagnostic Scale)
CGI-S (Clinical Global Impressions Severity Scale)
CGI-I (Clinical Global Impressions Improvement Scale)
SCL-90 (Symptom Checklist 90)
ESS (Epworth Sleepiness Scale)
BFI (Brief Fatigue Inventory)
FSS (Fatigue Severity Scale)
SOS (Severity of Symptoms Scale)
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 19 Jun 2013.
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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 Davidson, M.D. principal investigator
Duke Univeristy Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing modafinil in people with Atypical Depression, run by Duke University.
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 6 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 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
HAM-D-29 (Hamilton Depression 29-Item Scale, with Atypical Features). 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 19 Jun 2013.