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TCAs, SSRIs, NARIs, SNRIs, Lithium · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Continuation-Medication with Antidepressants (after WBS Guidelines) |
| 2 | EXPERIMENTAL | Continuation-ECT with Antidepressants |
| 3 | EXPERIMENTAL | Continuation-Psychotherapy (Cognitive Behavioral Group Psychotherapy including the "Situational Analysis" of CBASP) |
| Name | Type | Description |
|---|---|---|
| TCAs, SSRIs, NARIs, SNRIs, Lithium | DRUG | Antidepressant, dosage, and duration are chosen due to the guidelines of the WFSBP (Bauer et al. 2002) |
| 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. |
| 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. |
Inclusion Criteria: * Major depressive episode (unipolar) * Response to acute ECT (at least 50% reduction in HAMD) * Capacity to consent * Sufficient comprehension of the German language Exclusion Criteria: * Schizophrenia, schizoaffective disorder, or other psychosis * Amnestic disorder, dementi...
TCAs, SSRIs, NARIs, SNRIs, and Lithium are used for depression, specifically major depression. These are small molecule psychiatric medications being studied as continuation therapies after electroconvulsive therapy (ECT) in severely depressed patients. The drug combination is currently in Phase 1 clinical development.
Pulmonx Corporation (NASDAQ: LUNG) is developing TCAs, SSRIs, NARIs, SNRIs, and Lithium. The company is conducting a Phase 1 clinical trial for this combination therapy in depression. The trial is being run in Germany.
TCAs, SSRIs, NARIs, SNRIs, and Lithium are in Phase 1 clinical development. The drug is investigational and not yet approved for depression. One Phase 1 trial has been completed, and the drug remains in early-stage clinical testing.
TCAs, SSRIs, NARIs, SNRIs, and Lithium have one completed clinical trial, NCT00437385, titled "Evaluation of Three Continuation Therapies After ECT Concerning Efficacy and Cognition in Severely Depressed Patients." This Phase 1 study enrolled 90 participants with depression or major depression in Germany.
TCAs, SSRIs, NARIs, SNRIs, and Lithium are not FDA approved. The drug is investigational and in Phase 1 clinical development for depression. The completed trial NCT00437385 was an active-controlled, randomized study, but the drug has not received regulatory approval.