Effect of Motivational Therapy on Schizophrenia With Cann... | NCT00798109

Studies
Effect of Motivational Therapy on Schizophrenia With Cannabis Misuse

NCT00798109

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Jun 16, 2014Estimated

Enrollment

97Actual

Phase

Not Applicable

Conditions

Schizophrenia
Cannabis Dependence, Continuous

Interventions

Motivational therapy
Usual care

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
AOM 07007	Other Identifier	French Ministry

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Oct 2012Actual

Completion Date

Apr 2013Actual

First Submitted Date

Sep 30, 2008

First Submission Date that Met QC Criteria

Nov 24, 2008

First Posted Date

Nov 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2014

Last Update Posted Date

Jun 16, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Schizophrenia is a severe mental illness with a lifetime morbidity risk close to 1 %, involving both genetic and environmental risk factors. Prospective studies have shown that heavy use of cannabis in adolescence moderately increases the risk of developing schizophrenia. Many data have also suggested that the co-occurrence of cannabis abuse in patients with schizophrenia has a deleterious impact on the clinical outcome of schizophrenia. Cannabis abuse by schizophrenic patients is a significant public health problem for which there is no empirically validated treatment. We are presently studying the efficiency of motivational therapy on cannabis consumption in patients with schizophrenia.

Detailed Description

330 patients with schizophrenia and cannabis abuse or dependence (according to DSM-IV criteria) are randomly assigned to 4 motivational interview during one month or usual intensive treatment. Treatment is conducted in outpatient which are evaluated at the inclusion and at 6 month with Time-Line Follow Bach for the consumption, PANSS score, number of relapse…). A outcome measure was urinalysis results providing an objective measure of cannabis use throughout the six month of the trial.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Motivational Therapy	Experimental	Four motivational interview for cannabis abuse in schizophrenia population during one month	Behavioral: Motivational therapy
Usual Care	Other	Usual care with intensive psychotherapy	Behavioral: Usual care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Motivational therapy	Behavioral	One hour of motivational therapy each weak during 4 weeks	Motivational Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cannabis consumption evaluated by the Time-Line Follow Back at 6 months with mean percentage of abstinent day		inclusion, 3 month, 6 month, 12 month

Secondary Outcomes

Measure	Description	Time Frame
PANSS, GAF, number of DSM-IV criteria of cannabis dependence, May scale for treatment response, SF-12, la URICA, number of hospitalisation, mean number of joints per week, D9THC urinanalysis at 6M and cannabis consumption evaluated by the TLFB at 6M	PANSS : global, positive, negative, general scores	inclusion, 3 month, 6 month, 12 month. Only inclusion and 6 month for urianalysis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:

Schizophrenia or schizo-affective disorder according to DSM-IV criteria
Meeting DSM-IV criteria for actual cannabis abuse or dependance
in current and regular contact with mental health service
with an age at interview of 18 years or more
No evidence of organic brain disease or clinically significant concurrent medical illness or learning disability
Written informed consent was obtained from all subjects (patients and parents).

EXCLUSION CRITERIA:

Not membership to a regime of social security or to a CMU

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Caroline DUBERTRET, MD,PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de psychiatrie (Pr Adès)		Colombes		92700	France

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D002189	Marijuana Abuse

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders

Browse Leaves

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Browse Branches

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