Depressive DisorderNCT00337012
The Effect of Duloxetine on Interoceptive Awareness
An observational study of Depressive Disorder, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
This study focuses on possible mechanism mediating duloxetine effects on painful physical symptoms in patients suffering from MDD. Our hypothesis is based on the assump¬tion of dual impairment of the somatosensory system in these patients. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2007to not given
- Phase
- Observational
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female (female are enrolled only under the condition of proof of using a safe and medially accepted contraceptive. According to the "Note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals" (CPMP/ICH/286/95, modification) contraceptives with a pearl-index<1% are considered safe and effective. Among these only hormonal contraceptives, micro-pill and tubal ligantions will be accepted in this study)
- Between the ages of 21 and 65 years; and
- A diagnosis of major depression (HDRS>=15) and
- A minimum of 25 mm on a VAS measure of painful symptoms (ranging from 0-100 mm), but no need for regular pain medication and HAMD-17 item 13 minimum rated as 1,
- Medically and neurologically healthy on the basis of history, physical examination, EKG, screening laboratories (CBC w/ differential, TSH, Free-T4, ASAT, ALAT, GGT, BUN, creatinine, calcium, phosphorous, magnesium, total protein, albumin, electrolytes) and
- Absence of substance abuse on the basis of history and urine toxicology at screening.
Who cannot join
- DSM-IV psychiatric and substance abuse diagnosis (excluding nicotine dependence) by history or psychiatric evaluation that includes a structured diagnostic interview for non-patient populations (SCID-NP)
- Current suicide risk sufficient to preclude treatment on an outpatient base: Higher than "2" on the "suicide" item of HAMD-17, or history of suicide attempt(s) in the past 12 months, or who, in the investigator's judgment, poses a current suicidal or homicidal risk.
- Clinical indications of organic brain disease, dementia, or cognitive impairment.
- History of substance dependence other than nicotine and consumption within the last year
- Any medical condition that would preclude the use of duloxetine treatment as
- A known hypersensitivity to duloxetine or any of the inactive ingredients.
Show all 12Show fewer
- Intake of monoamine oxidase inhibitors (MAOIs) or suffering from uncontrolled narrow-angle glaucoma.
- Signs of any hepatic insufficiency
- Intake of inhibitors of CYP1A2 (as fluvoxamine, ciprofloxacin, enoxacin)
- End-stage renal disease (requiring dialysis) or severe renal impairment (estimated creatinine clearance [CrCl] <30 mL/min)
- Subnormal intellectual potential as assessed by the WST-IQ [Metzler. und Schmidt, 1992]
- Healthy controls will meet exclusion and inclusion criteria, but will have no current or prior diagnosis of major depression.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Clinic Bonn
Bonn, North Rhine-Westphalia, 53105
Christian G Schütz, +49 228 2879664
About this study
Official title: The Effect of Duloxetine on Interoceptive Awareness, Thermal Heat Pain Perception, and Bodily Symptoms in Major Depressive: a Pilot Study With fMRI.
This study focuses on possible mechanism mediating duloxetine effects on painful physical symptoms in patients suffering from MDD. Our hypothesis is based on the assump¬tion of dual impairment of the somatosensory system in these patients. Hypalgesia to phasic experimental pain may be due to diminished spinal and brainstem transmission. Hyperalgesia may be at¬tributed to increased interoceptive perception (somatic complaints, especially those consist¬ing in pain) due to sensitisation or lack of inhibition of the interceptive perception. These ef¬fects seem to be mediated by specific brain regions (e.g. the right insula). The investigators intent to test if duloxetine effects on these somatic complaints, especially pain complaints are due to a nor¬malization of these interceptive alterations which have been reported to be associated with depressive symptoms. The investigators hypothesize that treatment with duloxetine will normalize "patho¬logical" activation patterns (as assessed by fMRI) associated with increased interoceptive perception.
- Conditions
- Depressive Disorder
- Medical subject headings
- Depressive Disorder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2006 (estimated)
- Study startJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Investigators
- Wolfgang Maier, Prof. Dr., Principal investigator, University of Bonn, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337012
- Sponsor's protocol ID
- 2006-001079-39
- Status last verified
- Nov 2008
- First submitted
- 13 Jun 2006
- Last updated
- 1 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Duloxetine on Interoceptive Awareness, Thermal Heat Pain Perception, and Bodily Symptoms in Major Depressive: a Pilot Study With fMRI.
- ClinicalTrials.gov ID
- NCT00337012
- Acronym / sponsor ID
- 2006-001079-39
- Conditions
- Depressive Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Jul 2007
- First posted
- 15 Jun 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 study focuses on possible mechanism mediating duloxetine effects on painful physical symptoms in patients suffering from MDD. Our hypothesis is based on the assump¬tion of dual impairment of the somatosensory system in these patients. Hypalgesia to phasic experimental pain may be due to diminished spinal and brainstem transmission. Hyperalgesia may be at¬tributed to increased interoceptive perception (somatic complaints, especially those consist¬ing in pain) due to sensitisation or lack of inhibition of the interceptive perception. These ef¬fects seem to be mediated by specific brain regions (e.g. the right insula). The investigators intent to test if duloxetine effects on these somatic complaints, especially pain complaints are due to a nor¬malization of these interceptive alterations which have been reported to be associated with depressive symptoms. The investigators hypothesize that treatment with duloxetine will normalize "patho¬logical" activation patterns (as assessed by fMRI) associated with increased interoceptive perception.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female (female are enrolled only under the condition of proof of using a safe and medially accepted contraceptive. According to the "Note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals" (CPMP/ICH/286/95, modification) contraceptives with a pearl-index<1% are considered safe and effective. Among these only hormonal contraceptives, micro-pill and tubal ligantions will be accepted in this study)
- Between the ages of 21 and 65 years; and
- A diagnosis of major depression (HDRS>=15) and
- A minimum of 25 mm on a VAS measure of painful symptoms (ranging from 0-100 mm), but no need for regular pain medication and HAMD-17 item 13 minimum rated as 1,
- Medically and neurologically healthy on the basis of history, physical examination, EKG, screening laboratories (CBC w/ differential, TSH, Free-T4, ASAT, ALAT, GGT, BUN, creatinine, calcium, phosphorous, magnesium, total protein, albumin, electrolytes) and
Key exclusion criteria (12 listed)
- DSM-IV psychiatric and substance abuse diagnosis (excluding nicotine dependence) by history or psychiatric evaluation that includes a structured diagnostic interview for non-patient populations (SCID-NP)
- Current suicide risk sufficient to preclude treatment on an outpatient base: Higher than "2" on the "suicide" item of HAMD-17, or history of suicide attempt(s) in the past 12 months, or who, in the investigator's judgment, poses a current suicidal or homicidal risk.
- Clinical indications of organic brain disease, dementia, or cognitive impairment.
- History of substance dependence other than nicotine and consumption within the last year
- Any medical condition that would preclude the use of duloxetine treatment as
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2008.
Related trials for Depressive Disorder
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Wolfgang Maier, Prof. Dr. principal investigator
University of Bonn, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, run by University Hospital, Bonn at 1 site in Germany.
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 12 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: status not confirmed, as of the sponsor's last update on 1 Dec 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian G Schuetz, MD MPH (+49 228 287 9664, christian.schütz@ukb.uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 1 Dec 2008.