SchizophreniaNCT04268797
TMS in Treatment of Schizophrenia Negative Symptoms
A study testing HR rTMS in people with Schizophrenia, run by Sveti Ivan Psychiatric Hospital at 1 site in Croatia.
Trial summary
Primary objective: to examine the efficacy and safety of high frequency repetitive transcranial magnetic stimulation (HF rTMS) with H7-coil applied once daily during the twenty days, augmentative to the standard antipsychotic pharmacotherapy and other treatment of negative symptoms in schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- HR rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteCroatia
- Study dates
- 4 Nov 2019to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Confirmation diagnosis of schizophrenia (ICD-10 F20) using the Mini-International Neuropsychiatric Interview (MINI) (Lecrubier et al., 1997; Sheehan et al., 1998),
- Age 18-55 years,
- Both genders,
- PANSS negative symptoms subscale score >24,
- PANSS positive symptoms subscale score <20,
- Stable condition (no acute psychosis exacerbation, no psychiatric hospitalization because of relapse or worsening of symptoms) during at least three months,
- Stable antipsychotic therapy with no change of drugs or doses during the one months before the enrollment.
Who cannot join
- Antipsychotics dose change or change of antipsychotic drug,
- Hospitalization for somatic illness in another institution,
- Termination of treatment in a Psychiatric Hospital "Sveti Ivan",
- Pregnancy,
- Missed more than three consecutive interventions,
- Withdrawal of consent to participate for the sake of intolerance of TMS or for other reasons.
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
PB Sveti Ivan
Zagreb, 10000
Ena Ivezic, MA, 38513430171, ena.ivezic@pbsvi.hr
About this study
Official title: Efficacy and Safety of High-frequency Repetitive Transcranial Magnetic Stimulation With H7-coil in the Treatment of Schizophrenia Negative Symptoms; A Multicenter, Randomized, Sham Controlled, Triple Blind Trial
Primary objective: to examine the efficacy and safety of high frequency repetitive transcranial magnetic stimulation (HF rTMS) with H7-coil applied once daily during the twenty days, augmentative to the standard antipsychotic pharmacotherapy and other treatment of negative symptoms in schizophrenia.
Targeted population: patients diagnosed with schizophrenia, 18-55 years old with predominant negative symptoms, stable condition for >3 months and unchanged antipsychotic therapy for >1 months and no treatment with antidepressants.
Read more
Study design: industry independent, multicenter, prospective randomized sham-controlled, two-arms, triple-blind superiority clinical trial with concealed allocation and masked independent outcome assessment.
Primary outcome: adjusted median of differences in total SANS score. Adjustment for age, gender, baseline total SANS score, duration of the disorder, and antipsychotic therapy.
- Conditions
- Schizophrenia
- Being tested
- HR rTMS, sham
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR rTMSDevice
high frequency repetitive transcranial magnetic stimulation (HF rTMS) with H7-coil applied once daily during the twenty days
shamDevice
SHAM HF rTMS coil once daily x 20 days
| Study group | Role | What they receive |
|---|---|---|
| HR rTMS H7-coil intervention group | Experimental | Not described Receives: Device: HR rTMS |
| sham control group | Sham comparator | Not described Receives: Device: sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted median of differences in total SANS score
Adjusted median of differences in total SANS score (Andreasen, 1989). We will adjust the medians for age, gender, baseline total SANS score, duration of the disorder, and antipsychotic therapy
Measured: assessed up to 20 days of treatment
Secondary outcomes (4)
Change in SNS score
Change in Self-Evaluation of Negative Symptoms Scale (SNS) (Dollfus, Mach and Morello, 2016)
Measured: assessed up to 20 days of treatment
Change of BNSS score
Change in Brief Negative Symptom Scale (BNSS), (Kirkpatrick et al., 2006)
Measured: assessed up to 20 days of treatment
Change in PANSS negative symptom subscale with items rescaled to 0-6 range
Change in PANSS negative symptoms subscale with items rescaled to 0-6 range, (Kay, Fiszbein and Opler, 1987)
Measured: assessed up to 20 days of treatment
Change in CDSS score
Change in depressive symptoms measured using Calgary Depression Scale for Schizophrenia (CDSS) (Addington, Addington and Schissel, 1990)
Measured: assessed up to 20 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start4 Nov 2019
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sveti Ivan Psychiatric Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268797
- Sponsor's protocol ID
- TMS_negative symptoms
- Status last verified
- May 2022
- First submitted
- 7 Feb 2020
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of High-frequency Repetitive Transcranial Magnetic Stimulation With H7-coil in the Treatment of Schizophrenia Negative Symptoms; A Multicenter, Randomized, Sham Controlled, Triple Blind Trial
- ClinicalTrials.gov ID
- NCT04268797
- Acronym / sponsor ID
- TMS_negative symptoms
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Sveti Ivan Psychiatric HospitalUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Mar 2023 (estimated)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective: to examine the efficacy and safety of high frequency repetitive transcranial magnetic stimulation (HF rTMS) with H7-coil applied once daily during the twenty days, augmentative to the standard antipsychotic pharmacotherapy and other treatment of negative symptoms in schizophrenia.
Targeted population: patients diagnosed with schizophrenia, 18-55 years old with predominant negative symptoms, stable condition for >3 months and unchanged antipsychotic therapy for >1 months and no treatment with antidepressants.
Study design: industry independent, multicenter, prospective randomized sham-controlled, two-arms, triple-blind superiority clinical trial with concealed allocation and masked independent outcome assessment.
Primary outcome: adjusted median of differences in total SANS score. Adjustment for age, gender, baseline total SANS score, duration of the disorder, and antipsychotic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HR rTMS H7-coil intervention group | Experimental | Device: HR rTMS |
| sham control group | Sham comparator | Device: sham |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Confirmation diagnosis of schizophrenia (ICD-10 F20) using the Mini-International Neuropsychiatric Interview (MINI) (Lecrubier et al., 1997; Sheehan et al., 1998),
- Age 18-55 years,
- Both genders,
- PANSS negative symptoms subscale score >24,
- PANSS positive symptoms subscale score <20,
Key exclusion criteria (6 listed)
- Antipsychotics dose change or change of antipsychotic drug,
- Hospitalization for somatic illness in another institution,
- Termination of treatment in a Psychiatric Hospital "Sveti Ivan",
- Pregnancy,
- Missed more than three consecutive interventions,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR rTMShigh frequency repetitive transcranial magnetic stimulation (HF rTMS) with H7-coil applied once daily during the twenty days | Device | HR rTMS H7-coil intervention group |
| shamSHAM HF rTMS coil once daily x 20 days | Device | sham control group |
Primary outcome
Adjusted median of differences in total SANS score
Time frame: assessed up to 20 days of treatment
Adjusted median of differences in total SANS score (Andreasen, 1989). We will adjust the medians for age, gender, baseline total SANS score, duration of the disorder, and antipsychotic therapy
4 secondary outcomes
Change in SNS score
Time frame: assessed up to 20 days of treatment
Change of BNSS score
Time frame: assessed up to 20 days of treatment
Change in PANSS negative symptom subscale with items rescaled to 0-6 range
Time frame: assessed up to 20 days of treatment
Change in CDSS score
Time frame: assessed up to 20 days of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HR rTMS in people with Schizophrenia, run by Sveti Ivan Psychiatric Hospital at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adjusted median of differences in total SANS score (time frame: assessed up to 20 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.