SchizophreniaNCT00788970
Shiatsu Adjuvant Therapy And Placebo For Schizophrenia
A study testing Acupressure adjuvant therapy in people with Schizophrenia, run by Herzog Hospital at 1 site in Israel.
Trial summary
In the current study we will study the effect of adding acupressure (shiatsu) to conventional therapy in treating individuals with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Acupressure adjuvant therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Dec 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- Ages 18 and over
- Clinical status stable, as reflected by changes in Brief Psychiatric Rating Scale (BPRS) (Overall \& Gorham, 1961) of less than 20% during a one month period prior to randomization, and at least one month of drug treatment without change of anti-psychotic drug or dosage.
- Ability to cooperate with 40-minute sessions
Who cannot join
- Unstable general medical conditions
- Active bone fracture or other orthopedic problem
- Skin condition that renders treatment unsafe or painful
- Active infection in skin or soft tissues, such as cellulitis
- Solid tissue malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shiatsu Adjuvant Therapy And Placebo For Schizophrenia:a Double Blind Study
In the current study we will study the effect of adding acupressure (shiatsu) to conventional therapy in treating individuals with schizophrenia.
Read the detailed description
Acupressure, also known as shiatsu, is a holistic form of medicine originating in Japan but now widely practiced throughout the world. The theory is based on Traditional Chinese Medicine (TCM), which sees meridians of life force (chi) running through the body, and aims to optimize health through manipulating the body into maximal alignment.
We are proposing a randomized double-blind placebo-controlled trial to examine the efficacy of acupressure as adjuvant therapy added to antipsychotics in the treatment of patients with schizophrenia.
The goals of this study are twofold:
- To assess through the highest standards of empirical research whether acupressure can benefit patients with schizophrenia.
- To furnish data relevant to the possible physiological mechanisms by which acupressure may produce a therapeutic effect.
- Conditions
- Schizophrenia
- Being tested
- Acupressure adjuvant therapy
- Keywords
- Acupressure, Shiatsu, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure adjuvant therapyBehavioural
Also called Shiatsu
Acupressure provided in 40-minute sessions, twice a week for 4 weeks. For placebo acupressure, different meridian points will be used.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure | Experimental | Acupressure adjuvant therapy Receives: Behavioral: Acupressure adjuvant therapy |
| Placebo acupressure | Placebo comparator | Sham acupressure adjuvant therapy Receives: Behavioral: Acupressure adjuvant therapy |
| No treatment | No intervention | Wait list group (no treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Psychiatric Rating Scale (BPRS)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herzog Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Pesach Lichtenberg, M.D., Principal investigator, Herzog Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788970
- Sponsor's protocol ID
- lichtenberg3
- Status last verified
- Jan 2009
- First submitted
- 10 Nov 2008
- Last updated
- 13 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shiatsu Adjuvant Therapy And Placebo For Schizophrenia:a Double Blind Study
- ClinicalTrials.gov ID
- NCT00788970
- Acronym / sponsor ID
- lichtenberg3
- Conditions
- Schizophrenia
- Keywords
- Acupressure, Shiatsu, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Herzog HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 11 Nov 2008 (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.
In the current study we will study the effect of adding acupressure (shiatsu) to conventional therapy in treating individuals with schizophrenia.
Detailed description
Acupressure, also known as shiatsu, is a holistic form of medicine originating in Japan but now widely practiced throughout the world. The theory is based on Traditional Chinese Medicine (TCM), which sees meridians of life force (chi) running through the body, and aims to optimize health through manipulating the body into maximal alignment.
We are proposing a randomized double-blind placebo-controlled trial to examine the efficacy of acupressure as adjuvant therapy added to antipsychotics in the treatment of patients with schizophrenia.
The goals of this study are twofold:
- To assess through the highest standards of empirical research whether acupressure can benefit patients with schizophrenia.
- To furnish data relevant to the possible physiological mechanisms by which acupressure may produce a therapeutic effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupressure | Experimental | Behavioral: Acupressure adjuvant therapyAcupressure adjuvant therapy |
| Placebo acupressure | Placebo comparator | Behavioral: Acupressure adjuvant therapySham acupressure adjuvant therapy |
| No treatment | No intervention | –Wait list group (no treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- Ages 18 and over
- Clinical status stable, as reflected by changes in Brief Psychiatric Rating Scale (BPRS) (Overall \& Gorham, 1961) of less than 20% during a one month period prior to randomization, and at least one month of drug treatment without change of anti-psychotic drug or dosage.
- Ability to cooperate with 40-minute sessions
Key exclusion criteria (5 listed)
- Unstable general medical conditions
- Active bone fracture or other orthopedic problem
- Skin condition that renders treatment unsafe or painful
- Active infection in skin or soft tissues, such as cellulitis
- Solid tissue malignancy
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 |
|---|---|---|
| Acupressure adjuvant therapyAlso: ShiatsuAcupressure provided in 40-minute sessions, twice a week for 4 weeks. For placebo acupressure, different meridian points will be used. | Behavioural | Acupressure, Placebo acupressure |
Primary outcome
Brief Psychiatric Rating Scale (BPRS)
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2009.
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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.
Pesach Lichtenberg, M.D. principal investigator
Herzog Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure adjuvant therapy in people with Schizophrenia, run by Herzog Hospital at 1 site in Israel.
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 4 inclusion and 5 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 13 Jan 2009. 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 Israel. 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?
Contact Pesach Lichtenberg (972-2-5316929, licht@cc.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Psychiatric Rating Scale (BPRS) (time frame: 16 weeks). 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 13 Jan 2009.