Deep Phenotyping for Clinical Inferring Response in Treatment Resistant Depression

ConditionsDepressive; Disorder, Major, Single Episode, Major, With Psychotic Symptoms Depressive; Disorder, Major, Single Episode, Major (Without Psychotic Symptoms)Depressive Disorder, Major, Recurrent, With Psychotic Symptoms Depressive Disorder, Major, Recurrent, Without Psychotic Symptoms Depressive Disorder, Treatment-Resistant, Class I or II Depressive Disorder, Major, Moderate Depressive Disorder, Major, Severe

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorMax-Planck-Institute of Psychiatry

About this trial

DECIDE- Deep phenotyping for clinical inferring response in treatment resistant depression -Study

Building upon the "Biobanking" initiative at the Max Planck Institute of Psychiatry, the present project aims to identify clinically relevant subtypes of treatment-resistant depression (TRD) through Clinical Deep Phenotyping (CDP). According to clinical trials, 30-40% of the patients suffering from TRD benefit from lithium treatment. By collecting multimodal biological and clinical-diagnostic markers, such as structural and functional brain imaging via magnetic resonance imaging (MRI), brain signals from electroencephalography, comprehensive blood tests, assessment of perception and cognition through neuropsychological testing, as well as the evaluation of specific depression symptoms and psychological and other comorbidities using standardized questionnaires, a bio-clinical signature will be identified using multivariate machine learning algorithms as an integration method. This signature aims to predict the response to lithium therapy in TRD. Prospectively, such an algorithm could later personalize the treatment decision of 'lithium administration in TRD'. This concept is in line with the Research Domain Criteria (RDoC) of the National Institute of Mental Health (NIH) and aims to offer lithium therapy as a personalized treatment strategy for TRD. Specifically, this means that the likelihood of treatment response can be estimated before administration based on the results of the present study, thus enabling lithium to be offered specifically to those patients who are likely to benefit from it. The study design is non-interventional, meaning the decision for lithium treatment is made for patients according to clinical routine in accordance with the recommendation of the German National Treatment Guideline (NVL) independent of study enrollment. Study participation does not influence treatment decisions for the patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Obligated Participation in "Biobanking" of Max Planck Institute of psychiatry

Age: ≥18 years

DSM-V diagnosis of major depressive disorder (MDD; confirmed by Mini-Interview)

Treatment resistant depression (TRD): TRD stage I or TRD stage II

Disqualifiers

Age: < 18 years

Medical conditions incompatible with lithium therapy

History of hypomanic or manic episode

Two or more antidepressant substances simultaneously to lithium, except the combination with sleep-promoting antidepressants like Mirtazapine, Mianserin, or Trazodone

Trial population

patients treated at MPIP

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

multimodal and multivariate signature to predict outcome of lithium augmentation

Sensitivity and specificity of a multimodal and multivariate signature to predict outcome of lithium augmentation in TRD

Time frame

Timepoint: Baseline (Inclusion into study)

Secondary outcomes

Change in suicidality measured by the assessment of the Columbia-Suicide Severity Rating Scale (C-SSRS) between timepoints

Yes or No Questions, no Score applicable. Measures three items: Suicidal Ideation, Suicidal Behavior and Self-injurious Behavior without Suicidal Intent. Less YES answers indicate a better outcome.

Time frame

Timepoint: Baseline (Inclusion into study), Outcome (between week 3 to 6 - dependent on patients' course of disease)

Amount of Lithium Side effects using Lithium Side Effects Rating Scale

YES (mild, moderate, severe) or NO Questions. No Score applicable. The correlation between more side effects and treatment outcome are not known. Less YES answers indicate a better condition.

Time frame

Timepoint: Baseline (Inclusion into study), Follow up 2-6 (week 2 after an effective lithium level was achieved, week 3, week 4, week 5, week 6) and Outcome (between week 3 to 6 - dependent on patients' course of disease)

Clinician rated Response rate defined as a proportion with ≥ 50% reduction in baseline Montgomery Asberg Depression Scale

Overall Score Range 0 -60. Higher MADRS score indicates more severe depression.

Time frame

Timepoint: Baseline (Inclusion into study), Follow up 2, 4, 6, 7 (week 2 after an effective lithium level was achieved, week 4, week 6, week 52) and Outcome (between week 3 to 6 - dependent on patients' course of disease)

Clinician rated Remission rate defined as a Montgomery Asberg Depression Scale total score ≤10 Montgomery Asberg Depression Scale

Overall Score Range 0 -60. Higher MADRS score indicates more severe depression.

Time frame

Other outcomes

Identification of clinical predictors of treatment response to lithium namely the subtype of depression measured by the Inventory of Depressive Symptomatology (clinican rated version) with 30 items

total score range from 0 to 27, a higher score indicates a worse condition.

Time frame

Timepoint: Baseline (Inclusion into study), Outcome (between week 3 to 6 - dependent on patients' course of disease)

Identification of clinical predictors of treatment response to lithium namely the psychomotoric retardation grade measured by the Salpetriere retardation scale (SRRS, clinican rated)

Total score range 0-60, a higher score indicates a worse condition.

Time frame

Timepoint: Baseline (Inclusion into study), Outcome (between week 3 to 6 - dependent on patients' course of disease)

Deep classification of underlying depression by the Brief Resilience Scale Score

Total range 6-30, a lower score indicates a worse condition.

Time frame

Timepoint: Baseline (Inclusion into study)

Identification of clinical predictors of treatment response to lithium namely maladaptive personality traits measured by the Persönlichkeitsinventar für DSM-5 und ICD-11 - Kurzform - Version 1.1 (self-rating)

Lead to identification of maladaptive personality traits, no score on a scale.

Time frame

Timepoint: Baseline (Inclusion into study)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Max-Planck-Institute of Psychiatry

Lead sponsor

Source ClinicalTrials.gov

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