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| Sponsor: | Rigshospitalet, Denmark |
|---|---|
| Information provided by: | Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier: | NCT00379886 |
Purpose
Electroconvulsive therapy is the most effective treatment in severe depression and the effect is related to the generalized seizure induced by the treatment. General anesthesia is used during the treatment. Since only a brief period of unconsciousness is required anesthetics with a rapid recovery profile are used.
Methohexital, a barbiturat, is internationally considered "the golden standard", bot other short-acting anesthetics are used. In Denmark the most frequent used anestheticum for ECT is Thiopental, a barbiturat, but also Propofol, a non-barbiturat, is used in many psychiatric departments.
Several studies have shown that Propofol reduce seizure duration in comparison with barbiturates. So far, no studies have demonstrated any clinical implications of the reduced seiziure duration. However, these studies have included rather few patiens, most have been retrospective, and in the only prospective study conducted, uni-lateral ECT was used.
The aim of this study is to compare the clinical effect of ECT in patients anesthesized with either Propofol or Thiopental. The hypothesis is that the shorter duration of seizures found with Propofol as anestheticum will increase the number of treatments needed to clinial respons. Furthermore we want to study differences in EEG-relate parameters previously shown to have prognostic value. Hospitalized patients with major depression, who is to be treated with ECT, are randomized to anesthizia with either Thiopental or Propofol. They are rated with Hamilton depression scale and BDI before treatment, after six treatments and when treatment is concluded. When treatment is ended the patients are furthermore rated with MMSE to evaluate their degree of cognitive impairment.
| Condition | Intervention |
|---|---|
|
Depression |
Drug: Propofol Thiopental |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Comparison of Thiopental and Propofol as Anaesteticum During ECT |
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | December 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark, Copenhagen | |
| Rigshospitalet, Department of Psychiatry | Recruiting |
| Blegdamsvej 9, Copenhagen, Denmark, 2100 | |
| Contact: Jeanett Ø Bauer, MD, pHD 0045 35819411 jeanett.bauer@mail.dk | |
| Contact: Martin B Joergensen, M.D., pHD 0045 3545 6263 martinbj@rh.dk | |
| Principal Investigator: Jeanett Ø Bauer, M.D., pHD | |
| Principal Investigator: | Martin Balslev Jørgensen, M.D | Rigshospitalet, Department of Psychiatry, Copenhagen, Denmark |
More Information
| Study ID Numbers: | ECT-Jan2004-Jan2007 |
| Study First Received: | September 21, 2006 |
| Last Updated: | November 13, 2007 |
| ClinicalTrials.gov Identifier: | NCT00379886 History of Changes |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
|
ECT Depression Anesthiticum Propofol Thiopental |
|
Anesthetics, Intravenous Neurotransmitter Agents Depression Molecular Mechanisms of Pharmacological Action GABA Modulators Thiopental Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Depressive Disorder Pharmacologic Actions |
Behavioral Symptoms Mental Disorders Anesthetics, General Therapeutic Uses Hypnotics and Sedatives Mood Disorders GABA Agents Propofol Central Nervous System Agents Anticonvulsants |