Evidence map›Paper›PMID 42409979›Full record

ReviewDer Nervenarzt2026

[Psychotropic drug research in Germany: challenges of early benefit assessment and precision psychiatry].

Gerhard Gründer, Holger Bielen, Karl Broich, Silke Lipinski, Waltraud Rinke, Anne Röseler, Maximilian Schuier, Christoph von der Goltz, Marcus Weiland, Andreas Meyer-Lindenberg and 1 more

Abstract readEnglish AbstractReview
PubMed Publisher
In one paragraph

Review in Der Nervenarzt, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Gerhard GründerZentralinstitut für Seelische Gesundheit, J5, Medizinische Fakultät Mannheim, Universität Heidelberg, 68159, Mannheim, Deutschland. gerhard.gruender@zi-mannheim.de.
Holger BielenBiogen Deutschland GmbH, München, Deutschland.
Karl BroichBundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Deutschland.
Silke LipinskiHumboldt-Universität zu Berlin, Berlin, Deutschland.
Waltraud RinkeDeutsche DepressionsLiga e. V. (DDL), Bonn, Deutschland.
Anne RöselerBiogen Deutschland GmbH, München, Deutschland.
Maximilian SchuierJ&J Innovative Medicine, Janssen-Cilag GmbH, Johnson & Johnson, Neuss, Deutschland.
Christoph von der GoltzBoehringer Ingelheim International GmbH, Ingelheim am Rhein, Deutschland.
Marcus WeilandJ&J Innovative Medicine, Janssen-Cilag GmbH, Johnson & Johnson, Neuss, Deutschland.
Andreas Meyer-LindenbergZentralinstitut für Seelische Gesundheit, J5, Medizinische Fakultät Mannheim, Universität Heidelberg, 68159, Mannheim, Deutschland.
Andreas ReifKlinik für Psychiatrie, Psychosomatik und Psychotherapie, Universitätsklinikum Frankfurt - Goethe-Universität Frankfurt, Frankfurt am Main, Deutschland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe path to more precise and innovative psychotropic drugs is arduous and lengthy due to the complexity of mental illnesses and high regulatory hurdles. Nevertheless, several drugs have been developed and approved in the USA and the EU in recent years; however, not all of them were able to prevail in the benefit assessment in Germany. In order to exchange ideas about new precision medicine approaches as well as problems in the development and market access of psychotropic drugs and their possible solutions, the German Society of Psychiatry and Psychotherapy, Psychosomatics and Neurology (DGPPN) in cooperation with the House of Pharma & Healthcare hosted the round table on the future of psychotropic drug research in Frankfurt on 24 August 2023. Participants from clinical care, academic research, the pharmaceutical industry and patient representatives came together. RESEARCH QUESTION: What initiatives are necessary in the field of psychiatry research and regulation in order to successfully develop psychotropic drugs in Germany and to be able to introduce them into care? MATERIAL AND

methodThe article represents a synthesis of the lecture and discussion contributions of the 1‑day event.

resultsCurrent challenges are due to the fact that the biological mechanisms of mental illnesses are complex and heterogeneous and are insufficiently mapped by the current diagnostic entities. The benefit assessment of a preparation by the Federal Joint Committee (G-BA) often fails if an appropriate comparator therapy (zVT) cannot be reasonably selected or tested in a study. Platform studies (APT), which test the efficacy of several preparations at the same time with a control arm, can speed up the approval process and are meaningful. Consultations by the G‑BA in advance should be binding. The integration of empirical expertise can significantly enrich psychotropic drug research.

conclusionContinuous dialogue between authorities, economy, science, politics and representatives of those affected is needed to promote the development and approval of psychotropic drugs and thus improve the quality of life of patients.

Indexed as

AMNOG (Act on the Reorganisation of the Market for Medicinal Products)Benefit assessmentPrecision psychiatryPsychotropic drugsStudy designs

Identifiers

PMID42409979

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.