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Biological and psychological correlates of mental illnesses

Biological and neurocognitive markers in neuropsychiatry

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6y4ghx
Enrollment
Unknown
Registered
2015-04-14
Start date
2015-03-23
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Obsessive-compulsive disorder

Interventions

Fifty patients with obsessive-compulsive disorder will be randomized to receive one single session of transcranial direct current stimulation (1-2 mAs) on the supplementary motor area for 20 minutes (
Device

Sponsors

Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
Lead Sponsor
Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
Collaborator

Eligibility

Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Fifty patients with a diagnosis of obsessive-compulsive disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); aged between 18 and 50 years; with at least primary school; able to use computers; under regular pharmacological treatment for at least 3 months.

Exclusion criteria

Exclusion criteria: Any condition that hinders the smooth progress of the procedure as psychiatric comorbidities that impedes the assessment with the dotprobe task or with symptom severity scales; cardiac pacemakers and some brands of cerebral aneurysm clips; cochlear implants and neurostimulators; firearm projectiles and other metal fragments depending on the location in the body.

Design outcomes

Primary

MeasureTime frame
Main primary endpoint: reduction of attentional bias of patients with obsessive-compulsive disorder submitted to transcranial direct current stimulation. The Dot Probe Task will be used to verify the reduction of attentional bias. To determine the expected outcome, a statistically significant change on the average reaction time in milliseconds to stimuli related to obsessive-compulsive disorder presented in the dot-probe task before vs. after stimulation transcranial direct current will be used. Additional primary endpoint: reduction in the severity of obsessive-compulsive symptoms. To verify the reduction of obsessive-compulsive symptoms, the Yale-Brown Obsessive-Compulsive Challenge Scale will be used. To determine the expected outcome, a statistically significant decrease in the scores of Yale-Brown Obsessive-Compulsive Challenge scale after stimulation transcranial direct current will be used.

Secondary

MeasureTime frame
Main secondary endpoint: Reduction of obsessive-compulsive symptoms as categorical variable. To verify the status of response to treatment, the Yale-Brown obsessive compulsive challenge scale will be used. To determine the expected outcome, a decrease of at least 25% of the initial scores of the Yale-Brown obsessive -compulsive challenge after transcranial direct current stimulation will be used. Additional secondary endpoint: Reduction of negative affect. To verify the reduction of negative affect, the scale of positive and negative affects will be used. To determine the expected outcome, statistically significant decreases in negative subscores of the positive and negative affect scale after transcranial direct current stimulation will be used.

Countries

Brazil

Contacts

Public ContactLeonardo Fontenelle

Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro

leonardo.fontenelle@idor.org+55 (21) 3938-5555

Outcome results

None listed

Source: REBEC (via WHO ICTRP)