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A randomised, controlled trial to investigate the effect of a four/six week intensified pharmacological treatment for schizophrenia, major depressive disorder and bipolar depression compared to treatment as usual in subjects who had a first-time treatment failure on their first-line treatment.

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502185-24-00
Acronym
INTENSIFY
Enrollment
945
Registered
2023-06-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder or bipolar disorder type I and II (currently in a depressive episode)

Brief summary

Change in symptom severity total score from baseline (visit 2) to four-weeks (MDD)/six-weeks (SZ/BD) (visit 4). For SZ, this is measured using the Positive And Negative Syndrome Scale. For MDD and BD, Montgomery Asberg Depression Rating Scale is applied.

Detailed description

The secondary endpoints are already described in the secondary objectives

Interventions

DRUG-
DRUGESKETAMINE
DRUGBUPROPION
DRUGQUETIAPINE
DRUGVALPROIC ACID
DRUGVENLAFAXINE
DRUGLAMOTRIGINE
DRUGKETAMINE
DRUGSERTRALINE
DRUGDULOXETINE
DRUGCLOZAPINE
DRUGESCITALOPRAM
DRUGLITHIUM

Sponsors

University Medical Center Utrecht
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in symptom severity total score from baseline (visit 2) to four-weeks (MDD)/six-weeks (SZ/BD) (visit 4). For SZ, this is measured using the Positive And Negative Syndrome Scale. For MDD and BD, Montgomery Asberg Depression Rating Scale is applied.

Secondary

MeasureTime frame
The secondary endpoints are already described in the secondary objectives

Countries

Austria, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026