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DepressionPhase 1EffECTNCT00437385

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

A Phase 1 study testing TCAs, SSRIs, NARIs, SNRIs, Lithium, Electroconvulsive therapy and Cognitive behavioral group therapy in people with Depression and Major Depression, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Depression, Major Depression
What is being tested?
TCAs, SSRIs, NARIs, SNRIs, Lithium, Electroconvulsive therapy and Cognitive behavioral group therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteGermany
Study dates
Mar 2005to Mar 2011
Phase
Phase 1
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • ECT in the past 3 months
  • Acute suicidality
  • Judiciary hospitalization

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Berlin, State of Berlin, 14050

Other trials in Germany

About this study

Official title: Phase 1 Study: Evaluation of Three Continuation Therapies After Acute Electroconvusive Therapy (ECT) Concerning Efficacy and Cognition in Severly Depressed Patients

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.

Read the detailed description

BACKGROUND While electroconvulsive therapy (ECT) in major depression is effective, high relapse rates and cognitive effects limit its long-term use. Continuation treatment after ECT with combinations of C-ECT or psychotherapy and medication may decrease relapse rates and cognitive side effects while changing cognitive psychological variables like dysfunctional attitudes in the long-term.

CENTRAL RESEARCH QUESTIONS

  • Evaluation of the efficacy of three continuation treatments aimed at preventing relapses after acute ECT
  • Examination of the cognitive side effects and the changes of cognitive psychological variables during acute and continuation treatment

METHODS In a prospective, randomized, controlled, long-term study we assign 60 depressed ECT responder either to antidepressant treatment alone, or C-ECT plus medication, or cognitive behavioral group therapy plus medication. Depressive symptoms and cognition were assessed before, during, immediately after acute ECT and two, four, six, and 12 months during continuation therapy.

HYPOTHESES It is hypothesized that the use of combination continuation therapies after effective ECT leads to lower HAMD scores and lower relapse rates than the standard treatment with antidepressants alone after 6 months. In addition, we assume that the CBT group will establish more functional macro-patterns than the somatic treatments in the long term and will have the lowest HAMD scores and relapse rates after 1 year. With regard to the cognitive side effects, the autobiographical memory is expected to be the only specific part of memory being affected negatively by ECT in the short and long term.

Being tested
TCAs, SSRIs, NARIs, SNRIs, Lithium, Electroconvulsive therapy, Cognitive behavioral group therapy
Keywords
therapy resistant depression, severe depression
Medical subject headings
Depression, Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TCAs, SSRIs, NARIs, SNRIs, LithiumDrug

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

  • Electroconvulsive therapyProcedure or surgery

    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.

  • Cognitive behavioral group therapyBehavioural

    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.

Study groups in NCT00437385
Study groupRoleWhat they receive
1Active comparatorContinuation-Medication with Antidepressants (after WBS Guidelines)
Receives: Drug: TCAs, SSRIs, NARIs, SNRIs, Lithium
2ExperimentalContinuation-ECT with Antidepressants
Receives: Drug: TCAs, SSRIs, NARIs, SNRIs, Lithium; Procedure: Electroconvulsive therapy
3ExperimentalContinuation-Psychotherapy (Cognitive Behavioral Group Psychotherapy including the "Situational Analysis" of CBASP)
Receives: Drug: TCAs, SSRIs, NARIs, SNRIs, Lithium; Behavioral: Cognitive behavioral group therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Score on HAMD after 6 and 12 months

    Measured: 6 and 12 months after enetering continuation phase

Secondary outcomes (3)

  1. Relapse rate after 6 and 12 months

    Measured: 6 and 12 months after enetering continuation phase

  2. Response and remission rates after 6 and 12 months

    Measured: 6 and 12 months after enetering continuation phase

  3. Scores on MADRS, BDI, and CGI after 6 and 12 months

    Measured: 6 and 12 months after enetering continuation phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2007 (estimated)
  2. Study startMar 2005
  3. Primary completionMar 2010
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00437385
Sponsor's protocol ID
ek224-05b
Acronym
EffECT
Status last verified
Nov 2011
First submitted
20 Feb 2007
Last updated
10 Nov 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 11255384

  • 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.

    PubMed 10839336

  • 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.

    PubMed 17146008

  • 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.

    PubMed 24462229

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TCAs, SSRIs, NARIs, SNRIs, Lithium, Electroconvulsive therapy and Cognitive behavioral group therapy in people with Depression and Major Depression, run by Charite University, Berlin, Germany 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 4 inclusion and 9 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 10 Nov 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Score on HAMD after 6 and 12 months (time frame: 6 and 12 months after enetering continuation phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00437385, which also lists 4 linked publications.

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 10 Nov 2011.

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