NCT00328822

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

March 18, 2008

Status Verified

October 1, 2006

First QC Date

May 19, 2006

Last Update Submit

March 17, 2008

Conditions

Primary Insomnia

Keywords

Primary insomniaQuetiapineRandomized controlled trialDouble blind

Outcome Measures

Primary Outcomes (1)

  • Total Sleep Time

    3 weeks

Secondary Outcomes (1)

  • Sleep Latency Period, Sleep satisfaction

    3 weeks

Study Arms (2)

A

EXPERIMENTAL

Quetiapine

Drug: Quetiapine

B

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

QuetiapineDRUG
A
placeboDRUG
B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Srinagarind Hospital, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 20572379DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Kanida Tassniyom, MD

    Department of Psychiatry, Faculty of Medicine, Khon Kaen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2006

First Posted

May 22, 2006

Study Start

December 1, 2006

Study Completion

August 1, 2007

Last Updated

March 18, 2008

Record last verified: 2006-10

Locations

TH(1)