Deep Phenotyping for Clinical Inferring Response in Treatment Resistant Depression

NCT06396312 | Recruiting

• 1 other identifier: 24-0066
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depressive; 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

Keywords

Major depressive disorder; Depressive Disorder; Treatment-Resistant; biomarkers; Lithium; neuropsychology; circadian rhythm

Outcome Measures

Primary Outcomes (1)

• 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

  Timepoint: Baseline (Inclusion into study)

Secondary Outcomes (9)

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

  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

  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

  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

  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)

• Global improvement in Clinical Global Impression Score measured by the proportion of patients with an Improvement of much or very much improved (Clinican rating)

  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)

Other Outcomes (9)

• 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

  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)

  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

  Timepoint: Baseline (Inclusion into study)

Eligibility Criteria

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

Study Population

patients treated at MPIP

You may qualify if:

• 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
• Indication for antidepressant pharmacotherapy
• Indication for lithium augmentation
• Ability to provide informed consent

You may not qualify if:

• 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
• An alternative pharmacological augmentation strategy simultaneously to lithium disorder
• Quetiapine immediate- and extended release more than 100 mg in total
• Current substance use disorder except for moderate alcohol or benzodiazepine use bound to the current episode, or smoking
• Patients who are not suitable for the study in the opinion of the investigator
• Patients with a relevant comorbidity of the central nervous system such as focal neurological disease (stroke, tumour), current or past epilepsy, CNS inflammation including autoimmune disease, traumatic brain injury, past brain surgery
• Patients that are not able to provide informed consent
• Electroconvulsive therapy (ECT) in the current depressive episode
• Repetitive transcranial magnetic stimulation (rTMS) in the current depressive episode

Sponsors & Collaborators

• Max-Planck-Institute of Psychiatry: lead

Study Sites (1)

Max Planck Insitute of Psychiatry

Munich, Bavaria, 80804, Germany

RECRUITING

Related Publications (3)

• Bauer M, Dell'osso L, Kasper S, Pitchot W, Dencker Vansvik E, Kohler J, Jorgensen L, Montgomery SA. Extended-release quetiapine fumarate (quetiapine XR) monotherapy and quetiapine XR or lithium as add-on to antidepressants in patients with treatment-resistant major depressive disorder. J Affect Disord. 2013 Oct;151(1):209-19. doi: 10.1016/j.jad.2013.05.079. Epub 2013 Jun 27.

  PMID: 23810357 BACKGROUND

• Insel T, Cuthbert B, Garvey M, Heinssen R, Pine DS, Quinn K, Sanislow C, Wang P. Research domain criteria (RDoC): toward a new classification framework for research on mental disorders. Am J Psychiatry. 2010 Jul;167(7):748-51. doi: 10.1176/appi.ajp.2010.09091379. No abstract available.

  PMID: 20595427 BACKGROUND

• Bundesärztekammer (BÄK) KBK, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF). Nationalen VersorgungsLeitlinie (NVL) Unipolare Depression - Langfassung. 2022

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

biosamples for RNA isolation, Proteomics, Metabolomics, Exosomes, Genotyping, Methylation, drug levels and PBMC isolation

MeSH Terms

Conditions

Depressive Disorder; Recurrence; Lymphoma, Follicular; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Peter Falkai, MD

  Max-Planck-Institute of Psychiatry

  PRINCIPAL INVESTIGATOR

• Laura E Fischer, MD

  Max-Planck-Institute of Psychiatry

  PRINCIPAL INVESTIGATOR

• Florian Raabe, MD, PhD

  Max-Planck-Institute of Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura E Fischer, MD

CONTACT

0049-89-30622-1418; decide@psych.mpg.de

Florian Raabe, MD, PhD

CONTACT

0049-89-30622-1418; decide@psych.mpg.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: May 2, 2024
• Study Start: April 2, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: May 9, 2025

Record last verified: 2025-05

Locations

DE (1)