# Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure

Clinical trial · Dr. Inge Winter

- Archive id: nct:NCT05603104
- Published: 2022-11-02
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT05603104
- Source URL: https://clinicaltrials.gov/study/NCT05603104
- Provenance: clinicaltrials

## Abstract

Schizophrenia, bipolar and major depressive disorders collectively affect over 10 million people across the EU and are associated with annual healthcare and societal costs in excess of 100 billion Euros. When diagnosed with one of these disorders, patients are prescribed psychotropic medication such as antidepressants, mood stabilisers or antipsychotics. It is unknown whether this first-line treatment will be successful. After this first-line treatment fails, usually a second-line treatment is initiated, and when this is not successful either a third-line treatment is initiated. Third-line treatments are quite successful, especially when compared to second-line treatments. The research question is whether the third-line treatments (early-intensified treatments) when used earlier in the disease course for schizophrenia, bipolar and major depressive disorders. If this is indeed the case, this could lead to the prevention of unnecessary trials of ineffective treatments and adaptations of worldwide guidelines as well as a reduction of healthcare and societal costs.

_Abstract reproduced under ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters._

## Trial details

- acronym: INTENSIFY
- status: RECRUITING
- phase: PHASE3
- study type: INTERVENTIONAL
- enrollment: 1254
- sponsor: Dr. Inge Winter
- conditions: Schizophrenia and Related Disorders; Major Depressive Disorder; Bipolar Depression
- interventions: DRUG: Clozapine; DRUG: Esketamine Nasal Product; DRUG: Escitalopram; DRUG: Sertraline; DRUG: Venlafaxine; DRUG: Lithium; DRUG: Valproate acid; DRUG: Quetiapine; DRUG: Second-line Antidepressants; DRUG: Second-line Antipsychotics
- start date: 2025-04-27
- start date type: ACTUAL
- primary completion date: 2028-06-30
- has results: false
- data source: ClinicalTrials.gov
- data processed: 2026-10-29T09:00:05
- modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters

Topics: [Novel Psychiatric Therapeutics](https://space-kitty.com/topics/psychiatric-therapeutics)

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