NCT03921450: OCoPS-P

Overcoming Psychomotor Slowing in Psychosis (OCoPS-P)

Completed NA Last updated 14 February 2023

What this trial tests

NA trial testing 1 Hz rTMS in Schizophrenia and Related Disorders in 103 participants. Completed in 10 February 2023.

Timeline

25 March 2019

Primary endpoint
1 November 2022

10 February 2023

Quick facts

Lead sponsor	University of Bern
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	103
Start date	25 March 2019
Primary completion	1 November 2022
Estimated completion	10 February 2023
Sites	1 location across Switzerland

Drugs / interventions tested

• 1 Hz rTMS
• iTBS
• Placebo

Conditions studied

• Schizophrenia and Related Disorders — all drugs for Schizophrenia and Related Disorders →
• Schizophrenia — all drugs for Schizophrenia →
• Schizoaffective Disorder — all drugs for Schizoaffective Disorder →
• Brief Psychotic Disorder — all drugs for Brief Psychotic Disorder →

Sponsor

University of Bern

Who can join

Adults 18 to 60, any sex, with Schizophrenia and Related Disorders or Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Psychomotor slowing is a major problem in psychosis. Aberrant function of the cerebral motor system is linked to psychomotor slowing in patients, particularly resting state hyperactivity in premotor cortices. A previous clinical trial indicated that inhibitory stimulation of the premotor cortex would reduce psychomotor slowing. The current study is further exploring this effect in a randomized, placebo-controlled, double-blind design with three arms of transcranial magnetic stimulation and measures of brain imaging and physiology prior to and after the intervention.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Limbic links to paranoia: increased resting-state functional connectivity between amygdala, hippocampus and orbitofrontal cortex in schizophrenia patients with paranoia.
   Walther S, Lefebvre S, Conring F, Gangl N, et al · · 2022 · cited 43× · PMID 34636951 · DOI 10.1007/s00406-021-01337-w
2. The pathobiology of psychomotor slowing in psychosis: altered cortical excitability and connectivity.
   Lefebvre S, Gehrig G, Nadesalingam N, Nuoffer MG, et al · · 2024 · cited 28× · PMID 38537253 · DOI 10.1093/brain/awad395
3. Psychomotor Slowing in Psychosis and Inhibitory Repetitive Transcranial Magnetic Stimulation: A Randomized Clinical Trial.
   Walther S, Alexaki D, Weiss F, Baumann-Gama D, et al · · 2024 · cited 25× · PMID 38416468 · DOI 10.1001/jamapsychiatry.2024.0026
4. The Behavioral Mapping of Psychomotor Slowing in Psychosis Demonstrates Heterogeneity Among Patients Suggesting Distinct Pathobiology.
   Nadesalingam N, Lefebvre S, Alexaki D, Baumann Gama D, et al · · 2023 · cited 18× · PMID 36413085 · DOI 10.1093/schbul/sbac170
5. Neural Correlates of Formal Thought Disorder Dimensions in Psychosis.
   Maderthaner L, Pavlidou A, Lefebvre S, Nadesalingam N, et al · · 2023 · cited 16× · PMID 36946525 · DOI 10.1093/schbul/sbac120
6. Psychomotor slowing alters gait velocity, cadence, and stride length and indicates negative symptom severity in psychosis.
   Nuoffer MG, Lefebvre S, Nadesalingam N, Alexaki D, et al · · 2022 · cited 12× · PMID 36585399 · DOI 10.1038/s41537-022-00324-x
7. Measuring catatonia motor behavior with objective instrumentation.
   von Känel S, Nadesalingam N, Alexaki D, Baumann Gama D, et al · · 2022 · cited 12× · PMID 36061273 · DOI 10.3389/fpsyt.2022.880747
8. Using Virtual Reality as a Tool in the Rehabilitation of Movement Abnormalities in Schizophrenia.
   Pavlidou A, Walther S. · · 2020 · cited 12× · PMID 33488466 · DOI 10.3389/fpsyg.2020.607312