Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis

What Was Tested

The trial (phase 3) is built around Cyanocobalamin (Vitamin B12).

Chronic psychosis, including schizophrenia is now viewed as a progressive disorder where cognitive deficits predate the clinical onset.

It had four arms (groups): Treatment as usual (TAU) (active comparator), TAU + cognitive training (experimental), TAU + personalized neuroprotective strategies (experimental) and TAU + personalized neuroprotective strategies + cognitive training (experimental).

The registry classes the interventions as behavioral, drug and other.

Who Took Part

Enrollment: 500 planned participants were the target.

It was open to people of any sex aged from 15 years up to 30 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adolescent and young adults, both sexes, aged 15 to 30 years,. Persons characterised according to the CAARMS criteria \[8\] as UHR or FEP in the first year after having received diagnosis and care, if any. Informed and written signed consent,. Participant with regular health insurance.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: severe and unstabilised medical conditions,; insufficient level in reading and/or french language,; current participation in another intervention trial or in a full cognitive remediation programme,.

How the Study Was Run

Design: randomized, factorial and single-blind.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Only one side, usually the participants, was kept unaware of whether Cyanocobalamin (Vitamin B12) was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2023-12-15 with completion listed for 2026-12-15.

It ran at 13 sites in France (13).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Global functioning (time frame: 3 to 4 months after the beginning of intervention).

It also tracked 37 secondary outcomes, for example Efficiency of Composite Personalised Care (CPC) on clinical outcome (1), Efficiency of Composite Personalised Care (CPC) on clinical outcome (2), Efficiency of Composite Personalised Care (CPC) on clinical outcome (3), Efficiency of Composite Personalised Care (CPC) on clinical outcome (4), Efficiency of Composite Personalised Care (CPC) on clinical outcome (5) and Efficiency of Composite Personalised Care (CPC) on clinical outcome (6).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cyanocobalamin (Vitamin B12) in 500 people.

With 500 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.