Study on the Influence of Electroconvulsive Therapy (ECT) on Homocysteine Levels

NCT00370058 | Completed Phase 4

• 3 other identifiers: ECT and HomocysteineHomocysteinECT
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Elevated homocysteine levels are associated with depression and cognitive impairment. When depression ameliorates due to treatment, homocysteine serum levels often normalize. Aim of the present study is to investigate, whether repeated ECT treatment leads to changes in homocysteine levels and if these changes are associated with the occurrence of cognitive impairment after ECS. 10 patients suffering from therapy-resistant depression shall be enrolled. Patients are treated with repeated ECT (three times the week). Before, directly after and one day after ECT treatment, blood samples are drawn and patients receive cognitive testing. Depressive symptomatology is checked with different rating scales.

Conditions

Depressive Disorder, Major

Keywords

ect; depression; homocysteine; mthfr genotype

Outcome Measures

Primary Outcomes (1)

• Homocysteine serum levels

Secondary Outcomes (3)

• Cognitive functioning (e.g. concentration, memory tasks, etc.)

• Depressive symptomatology

• Measures of Seizure quality (duration, threshold, postictal suppression index, ...)

Interventions

ECT treatment PROCEDURE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18 years or above
• Diagnosis of major depressive disorder (according to DSM IV)
• Secured therapy resistance (at least two trials with antidepressive medication of different classes for more then 4 weeks in adequate dosage)
• Written, informed consent

You may not qualify if:

• Major neurological or other diseases
• Current medication with antiepileptic drugs
• History of major head trauma
• Any medical condition not allowing anesthesia

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg

Erlangen, 91054, Germany

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Epilepsy, Rolandic; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Behavioral Symptoms; Behavior

Study Officials

• Stefan Bleich, M.D.

  University Erlangen-Nuremberg

  PRINCIPAL INVESTIGATOR

• Wolfgang Sperling, M.D.

  University of Erlangen-Nürnberg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 29, 2006
• First Posted: August 30, 2006
• Study Start: August 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

DE (1)