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New treatment option for Gambling Disorder
Official title Modulating Inhibitory Control Networks in Gambling Disorder With Theta Burst Stimulation
ClinicalTrials.gov ID: NCT03669315
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- DSM-5 diagnosis of Gambling Disorder
- Age between 18 and 65 years
You likely can't join if
- any additional current psychiatric comorbidity, except for nicotine addiction;
- a lifetime DSM-5 diagnosis of schizophrenia or other psychotic syndromes, substance dependence or substance abuse, including alcohol, bipolar I or II...
- serious suicide risk;
- illness duration less than two years;
- hospitalization in the last 6 months;
- the inability to receive TMS because of metallic implants, or history of seizures (personal or family history of seizure in first degree relatives);
See the full eligibility criteria
- DSM-5 diagnosis of Gambling Disorder
- Age between 18 and 65 years
- any additional current psychiatric comorbidity, except for nicotine addiction;
- 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;
- serious suicide risk;
- illness duration less than two years;
- hospitalization in the last 6 months;
- the inability to receive TMS because of metallic implants, or history of seizures (personal or family history of seizure in first degree relatives);
- any major medical disease;
- pregnancy or nursing of an infant;
- the inability or refusal to provide written informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Florence, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Florence, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.