NCT03669315 Modulating Inhibitory Control Networks in Gambling Disorder With Theta Burst Stimulation
| NCT ID | NCT03669315 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | CNS Onlus |
| Condition | Gambling Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2018-05-20 |
| Primary Completion | 2019-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 40 participants in total. It began in 2018-05-20 with a primary completion date of 2019-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this project the investigators propose a randomized double-blind placebo-controlled design in which 40 patients with GD will receive active or sham cTBS to the pre-SMA for 2 weeks. The investigators will combine TMS, multimodal structural and functional MRI and behavioral measures in order to identify circuit-level mechanisms of action and therapeutic targets (connectivity changes that explain clinical improvement) and assess the efficacy of TMS in modulating inhibitory control and symptom severity in this population.
Eligibility Criteria
Inclusion Criteria: 1. DSM-5 diagnosis of Gambling Disorder 2. Age between 18 and 65 years Exclusion Criteria: 1. any additional current psychiatric comorbidity, except for nicotine addiction; 2. a lifetime DSM-5 diagnosis of schizophrenia or other psychotic syndromes, substance dependence or substance abuse, including alcohol, bipolar I or II disorder, mental disorder due to a general medical condition; 3. serious suicide risk; 4. illness duration less than two years; 5. hospitalization in the last 6 months; 6. the inability to receive TMS because of metallic implants, or history of seizures (personal or family history of seizure in first degree relatives); 7. any major medical disease; 8. pregnancy or nursing of an infant; 9. the inability or refusal to provide written informed consent.
Frequently Asked Questions
Who can join the NCT03669315 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Gambling Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03669315 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 40 participants.
Is NCT03669315 currently recruiting?
Yes, NCT03669315 is actively recruiting participants. Visit ClinicalTrials.gov or contact CNS Onlus to inquire about joining.
Where is the NCT03669315 trial being conducted?
This trial is being conducted at Florence, Italy.
Who is sponsoring the NCT03669315 clinical trial?
NCT03669315 is sponsored by CNS Onlus. The trial plans to enroll 40 participants.