Schizoaffective DisorderNCT02221635
Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of Schizoaffective
An observational study of Schizoaffective Disorder, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation in the prevention of relapse of the symptoms of schizoaffective disorder. Primary Outcome Measures:Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizoaffective Disorder
- What is being tested?
- rTMS + risperidone and Risperidone
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 540 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Jan 2015
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ages Eligible for Study: 18 Years to 65 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Who may be able to join
- DSM-IV (Diagnostic and Statistical Manual of Mental Disorders-IV)diagnosis of schizoaffective disorder
- Experiencing an acute exacerbation of psychotic symptoms
- A score of >=4 on at least 3 of the following 7 PANSS items: Delusions (P1), Hallucinatory behavior (P3), Excitement (P4), Hostility (P7), Tension (G4), Uncooperativeness (G8), and Poor Impulse Control (G14)
- A score of >=16 on YMRS and/or a score of >=16 on the HAM-D-21
- Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements
Who cannot join
- A primary active mental illness diagnosis other than schizoaffective disorder
- Have attempted suicide within 12 months or are at imminent risk of suicide or violent behavior
- Subjects with first episode of psychosis
- Received electroconvulsive therapy in the past 3 months
- History of hypersensitivity to or intolerance of paliperidone, risperidone, or 20% Intralipid (placebo)
- Received long-acting antipsychotic medication within 2 injection cycles
Show all 13Show fewer
- Received therapy with clozapine within 3 months
- A history of neuroleptic malignant syndrome
- Previous history of lack of response to antipsychotic medication
- Subjects receiving therapy with antidepressants or mood stabilizers that has been initiated and/or changed in dose <30 days prior to screening
- Receiving therapy with carbamazepine
- Receiving therapy with monoamine oxidase inhibitors
- Pregnant, breast-feeding, or planning to become pregnant
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qingrong
Xi'an, Shaanxi, 710032
Wang Hua Ning, Phd, 8613609161341, xskzhu@fmmu.edu.cn
Wang Hua ning, Phd
About this study
Official title: A Study to Evaluate the Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder
The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation in the prevention of relapse of the symptoms of schizoaffective disorder. Primary Outcome Measures:Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period. Secondary Outcome Measures: Symptom change as measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scores; Illness severity change as measured by Clinical Global Impression of Severity for depression (CGI-S-DEP); Change in subject functioning using the Personal and Social Performance Scale; Change in subject medication satisfaction using the Medication Satisfaction Questionnaire (MSQ).
Read the detailed description
Schizoaffective disorder is a chronic illness and generally requires life-long treatment. To date however, no physical therapy has been evaluated in the maintenance treatment of schizoaffective disorder. This is a randomized (study drug assigned by chance), double-blind (neither physician nor patient knows the name of the assigned drug), medication-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of repetitive transcranial magnetic stimulation(rTMS), as monotherapy or as an adjunct to antipsychotic, relative to antipsychotic drugs in delaying the time to relapse in patients with schizoaffective disorder. Patients with acute symptoms of schizoaffective disorder will be enrolled. The study will consist of 4 periods: an up to 7 days screening/tolerability period, a 6-week open-label flexible dose lead-in period, a 6-week open-label fixed dose stabilization period, and a 12 months double-blind relapse prevention period. Patients without previous exposure to rTMS will be given 4 to 6 days of rTMS for tolerability testing. Patients can continue their current antipsychotic drugs through Day-1 (the day before the start of the study period). During the open-label periods, all patients will be treated with Risperidone. Patients who meet pre-determined stabilization criteria will be eligible to enter the double-blind relapse prevention period and will be randomly assigned to either receive rTMS or rTMS+Risperidone treatment. Efficacy will be evaluated during the study using a relapse assessment(time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period). Secondary Outcome Measures:Secondary Outcome Measures: Symptom change as measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scores; Illness severity change as measured by Clinical Global Impression of Severity for depression(CGI-S-DEP); Change in subject functioning using the Personal and Social Performance Scale; Change in subject medication satisfaction using the Medication Satisfaction Questionnaire (MSQ). Safety will be assessed throughout the study by monitoring of adverse events, clinical laboratory tests, electrocardiograms (ECGs), vital sign measurements (temperature, pulse, and blood pressure), and weight. A 10 milliliter pharmacogenomic blood sample (sample for DNA research) will be collected from patients who give separate written informed consent for this part of the study.
- Conditions
- Schizoaffective Disorder
- Being tested
- rTMS + risperidone, Risperidone
- Keywords
- Schizoaffective Disorder, Repetitive transcranial magnetic stimulation (rTMS)
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS + risperidoneProcedure or surgery
Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks,than 2 sessions per week for 2 months, repeat that for 12 months. Meanwhile,risperidone (2-4 mg) was took orally.
RisperidoneDrug
Risperidone (2-4 mg) was took orally.
| Study group | Role | What they receive |
|---|---|---|
| rTMS+Risperidone | Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks,than 2 sessions per week for 2 months, repeat that for 12 months.At the same time,risperidone (2-4mg) was took orally. Receives: Procedure: rTMS + risperidone | |
| Risperidone | Risperidone (2-4mg) was took orally. Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for relapse
Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period.
Measured: Monthly during the 15 month double-blind Relapse Prevention Period.
Secondary outcomes (4)
Positive and Negative Syndrome Scale
Symptom change as measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scores
Measured: Up to 15 Months
Clinical Global Impression of Severity for Schizoaffective Disorder
Illness severity change as measured by Clinical Global Impression of Severity for Schizoaffective Disorder (CGI-S-SCA)
Measured: Up to 15 Months
Personal and Social Performance Scale
Change in subject functioning using the Personal and Social Performance Scale (PSP)
Measured: Up to 15 Months
Change in mood symptoms
Change in mood symptoms as measured by YMRS (Young Mania Rating Scale,in subjects with YMRS=16 at enrollment) and HAM-D-21) (in subjects with HAM-D-21=16 at enrollment)
Measured: Up to 15 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startMar 2013
- Primary completionDec 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizoaffective DisorderStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The No.3 hospital of PLA, The No.91 hospital of PLA, No. 102 Hospital of Chinese People's Liberation Army
- Responsible party
- Sponsor
- Investigators
- Tan QingRong, MD, Study chair, XiJing Hospital, Xi'An, Shanxi, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221635
- Sponsor's protocol ID
- Yunchun Chen
- Other IDs
- Xijing H
- Status last verified
- Aug 2014
- First submitted
- 19 Aug 2012
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT02221635
- Acronym / sponsor ID
- Yunchun Chen
- Conditions
- Schizoaffective Disorder
- Keywords
- Schizoaffective Disorder, Repetitive transcranial magnetic stimulation (rTMS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- The No.3 hospital of PLA, The No.91 hospital of PLA, No. 102 Hospital of Chinese People's Liberation Army
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 20 Aug 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.
The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation in the prevention of relapse of the symptoms of schizoaffective disorder. Primary Outcome Measures:Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period. Secondary Outcome Measures: Symptom change as measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scores; Illness severity change as measured by Clinical Global Impression of Severity for depression (CGI-S-DEP); Change in subject functioning using the Personal and Social Performance Scale; Change in subject medication satisfaction using the Medication Satisfaction Questionnaire (MSQ).
Detailed description
Schizoaffective disorder is a chronic illness and generally requires life-long treatment. To date however, no physical therapy has been evaluated in the maintenance treatment of schizoaffective disorder. This is a randomized (study drug assigned by chance), double-blind (neither physician nor patient knows the name of the assigned drug), medication-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of repetitive transcranial magnetic stimulation(rTMS), as monotherapy or as an adjunct to antipsychotic, relative to antipsychotic drugs in delaying the time to relapse in patients with schizoaffective disorder. Patients with acute symptoms of schizoaffective disorder will be enrolled. The study will consist of 4 periods: an up to 7 days screening/tolerability period, a 6-week open-label flexible dose lead-in period, a 6-week open-label fixed dose stabilization period, and a 12 months double-blind relapse prevention period. Patients without previous exposure to rTMS will be given 4 to 6 days of rTMS for tolerability testing. Patients can continue their current antipsychotic drugs through Day-1 (the day before the start of the study period). During the open-label periods, all patients will be treated with Risperidone. Patients who meet pre-determined stabilization criteria will be eligible to enter the double-blind relapse prevention period and will be randomly assigned to either receive rTMS or rTMS+Risperidone treatment. Efficacy will be evaluated during the study using a relapse assessment(time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period). Secondary Outcome Measures:Secondary Outcome Measures: Symptom change as measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scores; Illness severity change as measured by Clinical Global Impression of Severity for depression(CGI-S-DEP); Change in subject functioning using the Personal and Social Performance Scale; Change in subject medication satisfaction using the Medication Satisfaction Questionnaire (MSQ). Safety will be assessed throughout the study by monitoring of adverse events, clinical laboratory tests, electrocardiograms (ECGs), vital sign measurements (temperature, pulse, and blood pressure), and weight. A 10 milliliter pharmacogenomic blood sample (sample for DNA research) will be collected from patients who give separate written informed consent for this part of the study.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS+Risperidone | – | Procedure: rTMS + risperidoneIntensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks,than 2 sessions per week for 2 months, repeat that for 12 months.At the same time,risperidone (2-4mg) was took orally. |
| Risperidone | – | Drug: RisperidoneRisperidone (2-4mg) was took orally. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ages Eligible for Study: 18 Years to 65 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Key inclusion criteria (5 listed)
- DSM-IV (Diagnostic and Statistical Manual of Mental Disorders-IV)diagnosis of schizoaffective disorder
- Experiencing an acute exacerbation of psychotic symptoms
- A score of >=4 on at least 3 of the following 7 PANSS items: Delusions (P1), Hallucinatory behavior (P3), Excitement (P4), Hostility (P7), Tension (G4), Uncooperativeness (G8), and Poor Impulse Control (G14)
- A score of >=16 on YMRS and/or a score of >=16 on the HAM-D-21
- Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements
Key exclusion criteria (13 listed)
- A primary active mental illness diagnosis other than schizoaffective disorder
- Have attempted suicide within 12 months or are at imminent risk of suicide or violent behavior
- Subjects with first episode of psychosis
- Received electroconvulsive therapy in the past 3 months
- History of hypersensitivity to or intolerance of paliperidone, risperidone, or 20% Intralipid (placebo)
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 |
|---|---|---|
| rTMS + risperidoneIntensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks,than 2 sessions per week for 2 months, repeat that for 12 months. Meanwhile,risperidone (2-4 mg) was took orally. | Procedure or surgery | rTMS+Risperidone |
| RisperidoneRisperidone (2-4 mg) was took orally. | Drug | Risperidone |
Primary outcome
Time for relapse
Time frame: Monthly during the 15 month double-blind Relapse Prevention Period.
Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period.
4 secondary outcomes
Positive and Negative Syndrome Scale
Time frame: Up to 15 Months
Clinical Global Impression of Severity for Schizoaffective Disorder
Time frame: Up to 15 Months
Personal and Social Performance Scale
Time frame: Up to 15 Months
Change in mood symptoms
Time frame: Up to 15 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
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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.
Tan QingRong, MD study chair
XiJing Hospital, Xi'An, Shanxi, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizoaffective Disorder, run by Xijing Hospital at 1 site in China.
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 5 inclusion and 13 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 20 Aug 2014. 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 China. 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. 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?
Time for relapse (time frame: Monthly during the 15 month double-blind Relapse Prevention Period.). 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 20 Aug 2014.