Shiatsu Adjuvant Therapy And Placebo For Schizophrenia - Full Text View

Sponsored by:	Herzog Hospital
Information provided by:	Herzog Hospital
ClinicalTrials.gov Identifier:	NCT00788970

Purpose

In the current study we will study the effect of adding acupressure (shiatsu) to conventional therapy in treating individuals with schizophrenia.

Condition	Intervention
Schizophrenia	Behavioral: Acupressure adjuvant therapy

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study
Official Title:	Shiatsu Adjuvant Therapy And Placebo For Schizophrenia:a Double Blind Study

Further study details as provided by Herzog Hospital:

Primary Outcome Measures:

Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Acupressure: Experimental Acupressure adjuvant therapy	Behavioral: Acupressure adjuvant therapy Acupressure provided in 40-minute sessions, twice a week for 4 weeks. For placebo acupressure, different meridian points will be used.
Placebo acupressure: Placebo Comparator Sham acupressure adjuvant therapy	Behavioral: Acupressure adjuvant therapy Acupressure provided in 40-minute sessions, twice a week for 4 weeks. For placebo acupressure, different meridian points will be used.
No treatment: No Intervention Wait list group (no treatment)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788970

Contacts

Contact: Pesach Lichtenberg

972-2-5316929

licht@cc.huji.ac.il

Locations

Israel
Herzog Hospital, Department of Psychiatry
Jerusalem, Israel, 91351

Sponsors and Collaborators

Herzog Hospital

Investigators

Principal Investigator:

Pesach Lichtenberg, M.D.

Herzog Hospital

More Information

Responsible Party:	Herzog Hospital ( Dr. Pesach Lichtenberg )
Study ID Numbers:	lichtenberg3
Study First Received:	November 10, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00788970
Health Authority:	Israel: Ministry of Health

Keywords provided by Herzog Hospital:

Acupressure
Shiatsu
Schizophrenia

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 16, 2009