Quetiapine for Primary Insomnia Patients : A Randomized C... | NCT00328822

Studies
Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

NCT00328822

Sponsor

Khon Kaen University

Status

Completed

Last Update Posted

Mar 18, 2008Estimated

Enrollment

16Estimated

Phase

Not Applicable

Conditions

Primary Insomnia

Interventions

Quetiapine
placebo

Countries

Thailand

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

Status Module

Record Verification Date

Oct 2006

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

Dec 2006

Primary Completion Date

Not provided

Completion Date

Aug 2007Actual

First Submitted Date

May 19, 2006

First Submission Date that Met QC Criteria

May 19, 2006

First Posted Date

May 22, 2006Estimated

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

Mar 17, 2008

Last Update Posted Date

Mar 18, 2008Estimated

Description Module

Brief Summary

Primary insomnia patients will sleep with Quetiapine not better than without Quetiapine

Detailed Description

Primary insomnia will be diagnosed according to DSM-IV-TR
After consenting, cases will be divided (double blind randomization)in to two arms 2.1 sleep hygiene with placebo group 2.2 sleep hygiene with Quetiapine group
outcome measurement: sleep diary, sleep satisfaction visual analog scale and sleep satisfaction likert scale
statistical method: dependent T test

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

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Quetiapine	Drug: Quetiapine
B	Placebo Comparator	Placebo	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Quetiapine	Drug		A
placebo

Measure	Description	Time Frame
Total Sleep Time		3 weeks

Measure	Description	Time Frame
Sleep Latency Period, Sleep satisfaction		3 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary insomnia Patients by DSM-IV-TR criteria
cases enrolled: age 18-65 educated

Exclusion Criteria:

Currently receiving Quetiapine or other hypnotic drugs
Liver disease
Patients with heart Dz, Hypertension, thyroid disease
History of epilepsy or febrile convulsion
pregnant
cognitive impairments
History of Orthostatic Hypotension
Patient with other Psychiatric conditions or Drug dependence

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kanida Tassniyom, MD	Department of Psychiatry, Faculty of Medicine, Khon Kaen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Srinagarind Hospital, Khon Kaen University		Khon Kaen	Changwat Khon Kaen	40002	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20572379	Derived	Tassniyom K, Paholpak S, Tassniyom S, Kiewyoo J. Quetiapine for primary insomnia: a double blind, randomized controlled trial. J Med Assoc Thai. 2010 Jun;93(6):729-34.

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

ID	Term
D003987	Dibenzothiazepines
D013841	Thiazepines
D013846	Thiepins
D013457	Sulfur Compounds