Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT05603104

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

Led by Dr. Inge Winter · Updated on 2026-01-22

1254

Participants Needed

1

Research Sites

165 weeks

Total Duration

On this page

Sponsors

D

Dr. Inge Winter

Lead Sponsor

U

Universität Münster

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged at least 18 years up to 70 years (schizophrenia sample), up to 65 years (major depressive disorder sample), and no age limit for bipolar depression sample
  • Willing and able to provide written informed consent, with a legal guardian co-sign allowed
  • Female participants of childbearing potential must use effective contraception during the trial; male participants using valproate acid must use effective contraception
  • Diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder without psychotic features, or bipolar depression (type I or II currently depressive) confirmed by Mini International Neuropsychiatric Interview
  • Experienced treatment failure due to lack of efficacy in the current episode, preferably first-line treatment used for at least 4 weeks at effective dose
  • Participant and clinician intend to change pharmacological treatment
  • Minimum symptom severity threshold met: for schizophrenia, specific PANSS scores; for major depressive disorder and bipolar depression, MADRS score ≥ 20; plus functional impairment score ≥ 5 on Sheehan Disability Scale
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Previous failure on early-intensified pharmacological treatments (clozapine for schizophrenia, esketamine/ketamine for major depressive disorder)
  • Known intolerance or contraindication to study medications for each disorder group
  • Participation in another clinical trial with investigational drug within 30 days before study entry
  • Significant diseases or disorders posing risk or affecting participation or results
  • Active suicidal ideation with intent or plan deemed unsafe by clinician
  • Current severe substance use disorder (excluding nicotine, mild/moderate alcohol or cannabis)
  • Legal commitment or dependency on study sponsor, investigator, or site
  • For schizophrenia: meeting remission criteria or abnormal lab, ECG, or exam findings
  • For bipolar disorder: Young Mania Rating Scale score ≥ 12, history of antidepressant-induced mania/hypomania, recent rapid cycling, or severe liver damage

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sheba Medical Center

Ramat Gan, Israel

Actively Recruiting

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Research Team

I

Inge Winter, Dr.

CONTACT

C

Cynthia Okhuijsen-Pfeifer, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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