NCT01150734

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 22, 2011

Status Verified

April 1, 2011

Enrollment Period

1.2 years

First QC Date

June 23, 2010

Last Update Submit

April 21, 2011

Conditions

Keywords

differences of Muscle evoked potentials (MEP) in psychiatric illnessesdifferences in neuromodulationnormalization of neuromodulation after pharmacological treatment

Outcome Measures

Primary Outcomes (1)

  • Decreased MEP amplitudes in depressed patients

    MEP amplitudes are supposed to be lower than in healthy controls or schizophrenic patients

    at baseline

Secondary Outcomes (3)

  • Elevated MEP amplitudes in schizophrenic patients

    at baseline

  • Normalization of MEP amplitudes after drug treatment

    4 weeks after baseline

  • Normalization of MEP amplitudes after drug treatment

    4 weeks after baseline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

15 depressed patients 15 schizophrenic patients 15 healthy volunteers

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ludwig-Maximilians-University

Munich, 80333, Germany

Location

Related Links

MeSH Terms

Conditions

SchizophreniaDepression

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Frank Padberg, MD

    Ludwig-Maximilian-University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2010

First Posted

June 25, 2010

Study Start

October 1, 2009

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

April 22, 2011

Record last verified: 2011-04

Locations