SchizophreniaNCT01150734
Neuromodulation in Depressed and Schizophrenic Patients - Changing MEP (Muscle Evoked Potentials) by tDCS (Transcranial Direct Current Stimulation)
An observational study of Schizophrenia and Depression, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Muscle evoked potentials (MEP) are supposed to different in schizophrenic and depressed patients, compared to a sample of healthy volunteers. Transcranial Magnetic Stimulation (TMS)-evoked MEP are measured in all three groups at baseline and after tDCS (2 mA, 20 minutes). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Depression
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Jan 2011
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 15 depressed patients 15 schizophrenic patients 15 healthy volunteers
Who may be able to join
- The patient must be in the condition to understand the patient-information, as well as the necessary examinations.
- He/she must be able to give a written consent.
- No medication at least three weeks before enrollment.
Who cannot join
- Existence of a care/legal incapacity
- Existing pregnancy
- Severe psychiatric illness (with exception of affective disorder)
- Acute suicidality
- Drug-, medication- or alcohol dependence
- Dementia according to DSM IV / ICD 10-criterions
Show all 10Show fewer
- Severe brain infarctus in the anamnesis
- Indications of structural damage of the basal ganglia or the brain stem
- Severe neurological disorders (e.g. M. Parkinson, epilepsy, discus-prolapse, dementia, systemic neurological illnesses, normal pressure hydrocephalus, cerebrovascular diseases, elevated intracranial pressure, in the last 6 months, polyneuropathies).
- Severe other medical conditions, like manifest arterial hypertonia, severe heart disease, pacemakers, respiratory failure, malignant illnesses all type, also in the history, active infectious diseases, skeletal disorders (like M. Paget, osteoporosis with spontaneous fractures, fresh fractures) Other circumstances, that speaks against a participation of the patient pinion of Medical Doctor at this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Direct Current Stimulation (tDCS)-Boosted Changes in Muscle Evoked Potentials (MEP) in Depressed and Schizophrenic Patients Reveal Deficits in Neuromodulation
Muscle evoked potentials (MEP) are supposed to different in schizophrenic and depressed patients, compared to a sample of healthy volunteers. Transcranial Magnetic Stimulation (TMS)-evoked MEP are measured in all three groups at baseline and after tDCS (2 mA, 20 minutes). MEP amplitudes are supposed to normalize quickly in healthy volunteers, to stay diminished in depressed patients and to stay elevated in schizophrenic patients. These differences should disappear after regular pharmacological treatment. Outcome measures will be done in week 2 and week 4.
- Conditions
- Schizophrenia, Depression
- Keywords
- differences of Muscle evoked potentials (MEP) in psychiatric illnesses, differences in neuromodulation, normalization of neuromodulation after pharmacological treatment
- Medical subject headings
- Schizophrenia, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased MEP amplitudes in depressed patients
MEP amplitudes are supposed to be lower than in healthy controls or schizophrenic patients
Measured: at baseline
Secondary outcomes (3)
Elevated MEP amplitudes in schizophrenic patients
MEP amplitued are supposed to be elevated in schizophrenic patients in comparison to depressed patients or healthy controls
Measured: at baseline
Normalization of MEP amplitudes after drug treatment
MEP aplitued of schizophrenic patients are supposed to normalize after regular drug treatment within 4 weeks.
Measured: 4 weeks after baseline
Normalization of MEP amplitudes after drug treatment
MEP aplitued of depressed patients are supposed to normalize after regular drug treatment within 4 weeks.
Measured: 4 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Frank Padberg, MD, Study director, Ludwig-Maximilian-University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150734
- Sponsor's protocol ID
- 07/2009
- Status last verified
- Apr 2011
- First submitted
- 23 Jun 2010
- Last updated
- 22 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS)-Boosted Changes in Muscle Evoked Potentials (MEP) in Depressed and Schizophrenic Patients Reveal Deficits in Neuromodulation
- ClinicalTrials.gov ID
- NCT01150734
- Acronym / sponsor ID
- 07/2009
- Conditions
- Schizophrenia, Depression
- Keywords
- differences of Muscle evoked potentials (MEP) in psychiatric illnesses, differences in neuromodulation, normalization of neuromodulation after pharmacological treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 25 Jun 2010 (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.
Muscle evoked potentials (MEP) are supposed to different in schizophrenic and depressed patients, compared to a sample of healthy volunteers. Transcranial Magnetic Stimulation (TMS)-evoked MEP are measured in all three groups at baseline and after tDCS (2 mA, 20 minutes). MEP amplitudes are supposed to normalize quickly in healthy volunteers, to stay diminished in depressed patients and to stay elevated in schizophrenic patients. These differences should disappear after regular pharmacological treatment. Outcome measures will be done in week 2 and week 4.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 15 depressed patients 15 schizophrenic patients 15 healthy volunteers
Key inclusion criteria (3 listed)
- The patient must be in the condition to understand the patient-information, as well as the necessary examinations.
- He/she must be able to give a written consent.
- No medication at least three weeks before enrollment.
Key exclusion criteria (10 listed)
- Existence of a care/legal incapacity
- Existing pregnancy
- Severe psychiatric illness (with exception of affective disorder)
- Acute suicidality
- Drug-, medication- or alcohol dependence
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
Decreased MEP amplitudes in depressed patients
Time frame: at baseline
MEP amplitudes are supposed to be lower than in healthy controls or schizophrenic patients
3 secondary outcomes
Elevated MEP amplitudes in schizophrenic patients
Time frame: at baseline
Normalization of MEP amplitudes after drug treatment
Time frame: 4 weeks after baseline
Normalization of MEP amplitudes after drug treatment
Time frame: 4 weeks after baseline
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 22 Apr 2011.
- Related InfoLink 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.
Frank Padberg, MD study director
Ludwig-Maximilian-University
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 Schizophrenia and Depression, run by Ludwig-Maximilians - University of Munich 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 3 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 22 Apr 2011. 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?
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?
Decreased MEP amplitudes in depressed patients (time frame: at baseline). 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 22 Apr 2011.