Accelerated Neuromodulation Therapy for Negative Symptoms of Schizophrenia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDouglas Mental Health University Institute

About this trial

The goal of this clinical trial is to learn if an accelerated form of neuromodulation therapy can help improve negative symptoms of schizophrenia. Negative symptoms can include low motivation, reduced emotional expression, and difficulty with social interaction. The study will also look at how safe and tolerable this treatment is when given over a short period of time.

Participants will be randomly assigned to receive either active neuromodulation therapy or sham (placebo) stimulation. The study will also compare two different ways of choosing where to place the stimulation.

We want to learn whether this accelerated treatment approach is safe and feasible for people with schizophrenia, whether negative symptoms improve after treatment, and whether the way the stimulation site is chosen affects outcomes

Participants will be asked to complete clinical interviews and questionnaires, undergo a brain scan, receive neuromodulation therapy or sham stimulation over five consecutive days, and attend follow-up visits after treatment

This study is being conducted at three hospitals in Canada and is designed to help plan larger studies in the future.

Eligibility criteria

Qualifiers

Confirmed diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder

Duration of illness ≥ 6 months

Clinically significant negative symptoms

Must have been on a stable pharmacological treatment for at least 4 weeks before entering the study

Disqualifiers

Pregnancy, lactation, or an intrauterine device

History of electroconvulsive therapy (ECT) in the past 6 months

Use of licit or illicit substances (excluding cannabis) during the week of treatment and in the 24 hours prior to fMRI scans

Contraindications for TMS

Trial design

Treatments tested in this trial

  • Neuronavigated Intermittent Theta Burst Stimulation
  • BEAM-F3 Intermittent theta burst stimulation
  • Sham Intermittent Theta Burst Stimulation

Treatment groups

75 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Douglas Mental Health University Institute

Lead sponsor

Centre de recherche CERVO

Collaborator

Magnus Medical

Collaborator

Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

Collaborator