SchizophreniaNCT02105064
Repetitive Transcranial Magnetic Stimulation (rTMS) as an add-on Treatment for Resistant Obsessive-compulsive Symptoms in Patients With Schizophrenia
A study testing Active rTMS in people with Schizophrenia and Obsessive-Compulsive Symptoms, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
This is a study to evaluate the efficacy of rTMS for relief of obsessive-compulsive symptoms in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Obsessive-Compulsive Symptoms
- What is being tested?
- Active rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2011to Feb 2016
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Schizophrenia (DSM-IV-TR)
- YBOCS ≥ 16
Who cannot join
- Mental Retardation
- Substance abuse
- Any contraindication to rTMS
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
This is a study to evaluate the efficacy of rTMS for relief of obsessive-compulsive symptoms in patients with schizophrenia.
- Conditions
- Schizophrenia, Obsessive-Compulsive Symptoms
- Being tested
- Active rTMS, SHAM rTMS
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMSDevice
rTMS over supplementary motor area, 1hz, no pauses, 20 minutes/sessions, 5 sessions/week, 4 weeks. Total 20 sessions.
SHAM rTMSDevice
Sham rTMS, without brain stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Active comparator | rTMS over Supplementary Motor Area, 1hz, no pauses, 20 minutes per sessions. Total: 20 sessions. Receives: Device: Active rTMS |
| Sham | Sham comparator | Sham stimulation, 20 minutes per session, total 20 sessions Receives: Device: SHAM rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Obsessive Compulsive symptoms (using Yale-Brown Obsessive Compulsive Scale - Y-BOCS)
Measured: Baseline, after 20 rTMS sessions (an expected average of 4 weeks), and 4 weeks after end of treatment
Secondary outcomes (2)
Change of Psychotic Symptoms (using Brief Psychiatric Rating Scale - BPRS)
Measured: Baseline, after 20 rTMS sessions (an expected average of 4 weeks), and 4 weeks after end of treatment
Change of Brain-Derived Neurotrophic Factor (BDNF)
Measured: Baseline, after 20 rTMS sessions (an expected average of 4 weeks), and 4 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startJul 2011
- Primary completionDec 2014
- Study completionFeb 2016
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.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105064
- Sponsor's protocol ID
- 10-0426
- Status last verified
- Mar 2016
- First submitted
- 16 Sep 2013
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation (rTMS) as an add-on Treatment for Resistant Obsessive-compulsive Symptoms in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT02105064
- Acronym / sponsor ID
- 10-0426
- Conditions
- Schizophrenia, Obsessive-Compulsive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 7 Apr 2014 (estimated)
- 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.
This is a study to evaluate the efficacy of rTMS for relief of obsessive-compulsive symptoms in patients with schizophrenia.
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 |
|---|---|---|
| Active rTMS | Active comparator | Device: Active rTMSrTMS over Supplementary Motor Area, 1hz, no pauses, 20 minutes per sessions. Total: 20 sessions. |
| Sham | Sham comparator | Device: SHAM rTMSSham stimulation, 20 minutes per session, total 20 sessions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of Schizophrenia (DSM-IV-TR)
- YBOCS ≥ 16
Key exclusion criteria (3 listed)
- Mental Retardation
- Substance abuse
- Any contraindication to rTMS
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 |
|---|---|---|
| Active rTMSrTMS over supplementary motor area, 1hz, no pauses, 20 minutes/sessions, 5 sessions/week, 4 weeks. Total 20 sessions. | Device | Active rTMS |
| SHAM rTMSSham rTMS, without brain stimulation | Device | Sham |
Primary outcome
Change of Obsessive Compulsive symptoms (using Yale-Brown Obsessive Compulsive Scale - Y-BOCS)
Time frame: Baseline, after 20 rTMS sessions (an expected average of 4 weeks), and 4 weeks after end of treatment
2 secondary outcomes
Change of Psychotic Symptoms (using Brief Psychiatric Rating Scale - BPRS)
Time frame: Baseline, after 20 rTMS sessions (an expected average of 4 weeks), and 4 weeks after end of treatment
Change of Brain-Derived Neurotrophic Factor (BDNF)
Time frame: Baseline, after 20 rTMS sessions (an expected average of 4 weeks), and 4 weeks after end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active rTMS in people with Schizophrenia and Obsessive-Compulsive Symptoms, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 8 Mar 2016. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Obsessive Compulsive symptoms (using Yale-Brown Obsessive Compulsive Scale - Y-BOCS) (time frame: Baseline, after 20 rTMS sessions (an expected average of 4 weeks), and 4 weeks after end 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 8 Mar 2016.