Impact of tDCS on Cannabis Craving in Schizophrenia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentre hospitalier de Ville-Evrard, France
About this trial
This study aims to evaluate the tDCS's impact on cannabis craving in patients with schizophrenia and cannabis addiction disorder.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients (male or female) aged 18-65
Patients with schizophrenia according to DSM 5 criteria with Comorbid diagnosis of "cannabis use disorder"
conceptual disorganization
distrust
Disqualifiers
Presence of any other psychiatric disorder, as per DSM-5 criteria.
Pregnancy, possible pregnancy due to lack of contraception, breastfeeding.
Currently active suicidal or self-injurious ideation (suicidal or not)
Patients with Serious medical codition
Trial design
Design model
Parallel
Treatments tested in this trial
tDCS
DevicetDCS will be delivered using this electrode montage: anode on the left dosolateral prefrontal cortex (L DLPFC) using F3 EEG landmark and cathode on the left temporoparietal junction (L TPJ) on the middle point between T3 and P3 EEG landmark. The stimulation will be delivered at an intensity of 2 milliamps, for 20 minutes, five times a day, with 20 min inter sessions (it will be carried out on 5 consecutive days from Monday to Friday). Each processing day corresponds to a visit of V2, V3, V4, V5 and V6.
Treatment groups
138 Participants
are divided into 2 treatment groupsGroup A: Active transcranial direct current stimulation (active tDCS)Experimental treatment 1 intervention
Group B: Sham tDCSPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Marijuana Craving Questionnaire (MCQ)
To asses variation in cannabis craving state. The minimum value is 9 and the maximum value is 63.
Time frame
At baseline (Visit 2) and Day 5 (Visit 6)Secondary outcomes
1
Change in Score of the PANSS (Positive and Negative Syndrome Scale) to assess the psychopathology of schizophrenia
assessment of schizophrenia psychopathology. The minimum value is 7 and the maximum value is 49 for positive scale and negative scale. For general psychopathology, the minimum value is 16 and the maximum value is 112.
Time frame
At baseline (Visit 2) and Day 2, Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)2
Change in Score of SNS (schizophrenia negative symptoms) to assess negative symptoms
Assessment of schizophrenia negative symptoms. The total score is the sum of the 20 items, ranging from 0 (no negative symptoms) to 40 (severe negative symptoms).
Time frame
At baseline (Visit 2) and , Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)3
Change in Score of CGI (Clinical Global Impression) to clinical outcome
CGI scale assess clinical outcome
Time frame
At baseline (Visit 2) and, Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)4
Change in VAS score (visual analog scale) to assess the craving to cannabis
Cannabis craving status assessment. It is a ruler from 0 to 10 : 0 = absence of craving, 1-3 = low craving, 4-6 = moderate craving, 7-9 = intense craving, 10 = extreme craving.
Time frame
At baseline (Visit 2) and Day 2 (Visit 3), Day 3 (Visit 4),Day 4 (Visit 5), Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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