Evaluation of Three Continuation Therapies After ECT Concerning Efficacy and Cognition in Severly Depressed Patients

NCT00437385 | Completed Phase 1 DMC

• 1 other identifier: ek224-05b
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate three different continuation treatments after acute ECT concerning efficacy and impact on cognition in severly depressed patients.

Conditions

Depression; Major Depression

Keywords

therapy resistant depression, severe depression

Outcome Measures

Primary Outcomes (1)

• Score on HAMD after 6 and 12 months

  6 and 12 months after enetering continuation phase

Secondary Outcomes (3)

• Relapse rate after 6 and 12 months

  6 and 12 months after enetering continuation phase

• Response and remission rates after 6 and 12 months

  6 and 12 months after enetering continuation phase

• Scores on MADRS, BDI, and CGI after 6 and 12 months

  6 and 12 months after enetering continuation phase

Study Arms (3)

1

ACTIVE COMPARATOR

Continuation-Medication with Antidepressants (after WBS Guidelines)

Drug: TCAs, SSRIs, NARIs, SNRIs, Lithium

2

EXPERIMENTAL

Continuation-ECT with Antidepressants

Drug: TCAs, SSRIs, NARIs, SNRIs, Lithium; Procedure: Electroconvulsive therapy

3

EXPERIMENTAL

Continuation-Psychotherapy (Cognitive Behavioral Group Psychotherapy including the "Situational Analysis" of CBASP)

Drug: TCAs, SSRIs, NARIs, SNRIs, Lithium; Behavioral: Cognitive behavioral group therapy

Interventions

TCAs, SSRIs, NARIs, SNRIs, Lithium DRUG

Antidepressant, dosage, and duration are chosen due to the guidelines of the WFSBP (Bauer et al. 2002)

1; 2; 3

Electroconvulsive therapy PROCEDURE

ECT treatment is administered three times per week on non-successive weekdays and according to existing standards. Treatment lasts for at least three weeks (nine ECT sessions). Psychopharmacological treatment is continued during ECT treatment. Patients receive ultrabrief pulse (0.3 ms), unilateral treatment at a frequency of 40-100 Hertz. Stimulation is applied to the non-dominant hemisphere, according to the d'Elia electrode positioning paradigm. All patients are initially treated with right unilateral stimulation and in case of non-response switched to bilateral treatment. Stimulus intensity is chosen according to individual seizure threshold and administered at 2.5 to 6-fold intensity. During the ECT session, patients are anesthetized, under the influence of a muscle relaxant, and monitored regarding their vital functions.

2

Cognitive behavioral group therapy BEHAVIORAL

The continuation-psychotherapy (continuation cognitive behavioral therapy, C-CBT) sample took part in a newly developed cognitive behavioral group therapy program called "EffECTive". This therapy program was developed within the EffECT-project (Brakemeier et al. 2005), to fit the specific target group of patients finished with acute ECT-treatment. EffECTive is a group therapy that combines several aspects of existing cognitive-behavioral depression manuals with new elements (e.g., the situational analysis from CBASP, McCullough 2000), to fit the target group. Therapy sessions were held once a week and include approximately 15 sessions until follow-up.

3

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major depressive episode (unipolar)
• Response to acute ECT (at least 50% reduction in HAMD)
• Capacity to consent
• Sufficient comprehension of the German language

You may not qualify if:

• Schizophrenia, schizoaffective disorder, or other psychosis
• Amnestic disorder, dementia, or delirium
• Pregnancy
• Epilepsy
• Current alcohol or substance abuse or dependence
• CNS disease or brain injury not associated with psychotropic drug exposure
• ECT in the past 3 months
• Acute suicidality
• Judiciary hospitalization

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• German Research Foundation: collaborator

Study Sites (1)

Department of Psychiatry, Charité University Medicine, Campus Benjamin Franklin, Berlin, Germany

Berlin, State of Berlin, 14050, Germany

Location

Related Publications (4)

• Sackeim HA, Haskett RF, Mulsant BH, Thase ME, Mann JJ, Pettinati HM, Greenberg RM, Crowe RR, Cooper TB, Prudic J. Continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a randomized controlled trial. JAMA. 2001 Mar 14;285(10):1299-307. doi: 10.1001/jama.285.10.1299.

  PMID: 11255384 BACKGROUND

• Lisanby SH, Maddox JH, Prudic J, Devanand DP, Sackeim HA. The effects of electroconvulsive therapy on memory of autobiographical and public events. Arch Gen Psychiatry. 2000 Jun;57(6):581-90. doi: 10.1001/archpsyc.57.6.581.

  PMID: 10839336 BACKGROUND

• Kellner CH, Knapp RG, Petrides G, Rummans TA, Husain MM, Rasmussen K, Mueller M, Bernstein HJ, O'Connor K, Smith G, Biggs M, Bailine SH, Malur C, Yim E, McClintock S, Sampson S, Fink M. Continuation electroconvulsive therapy vs pharmacotherapy for relapse prevention in major depression: a multisite study from the Consortium for Research in Electroconvulsive Therapy (CORE). Arch Gen Psychiatry. 2006 Dec;63(12):1337-44. doi: 10.1001/archpsyc.63.12.1337.

  PMID: 17146008 BACKGROUND

• Brakemeier EL, Merkl A, Wilbertz G, Quante A, Regen F, Buhrsch N, van Hall F, Kischkel E, Danker-Hopfe H, Anghelescu I, Heuser I, Kathmann N, Bajbouj M. Cognitive-behavioral therapy as continuation treatment to sustain response after electroconvulsive therapy in depression: a randomized controlled trial. Biol Psychiatry. 2014 Aug 1;76(3):194-202. doi: 10.1016/j.biopsych.2013.11.030. Epub 2013 Dec 12.

  PMID: 24462229 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant

Interventions

Selective Serotonin Reuptake Inhibitors; Serotonin and Noradrenaline Reuptake Inhibitors; Lithium; Electroconvulsive Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Malek Bajbouj, PhD

  Department of Psychiatry, Charité University Medicine, Campus Benjamin Franklin, Berlin, Germany

  STUDY CHAIR

• Eva-Lotta Brakemeier, MA

  Department of Psychiatry and Psychotherapy, University Medicine, Freiburg, Germany

  PRINCIPAL INVESTIGATOR

• Norbert Kathmann, PhD

  Department of Clinical Psychology, Humboldt-University, Berlin, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. rer. nat.

Study Record Dates

• First Submitted: February 20, 2007
• First Posted: February 21, 2007
• Study Start: March 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2011
• Last Updated: November 10, 2011

Record last verified: 2011-11

Locations

DE (1)