CClinicalTrials.gg
CompletedNCT00206115Updated Jan 4, 2013

SR-Registration Study 1, ROW: Efficacy and Safety of Seroquel® in the Treatment of Patients With Schizophrenia

A Phase 3 interventional study of Seroquel Sustained Release (SR) and Seroquel Immediate Release (IR) in Schizophrenic Disorder, sponsored by AstraZeneca. Completed at 32 sites in 8 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-01-04.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
535
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this 6-week study is to determine whether treatment with Seroquel® Sustained Release (SR) is more effective than placebo in the treatment of acute schizophrenia.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

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Conditions studied

  • Schizophrenic Disorder

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Keywords

  • Schizophrenic disorder
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In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 535 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • To be considered for this study the patients should be aged between 18 to 65 years, need to suffer from schizophrenia and must be willing to participate.

Exclusion criteria

Exclusion Criteria:

  • Patients that suffer from psychiatric disorders other than schizophrenia including drug abuse and dependence, or medical conditions such as specific kidney, heart or thyroid problems, and patients with a known lack of response to drugs for schizophrenia will not be considered for this study.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
535 participants

Interventions

  • DrugSeroquel Sustained Release (SR)
  • DrugSeroquel Immediate Release (IR)
  • DrugPlacebo
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What researchers measure

Primary outcomes

  1. The primary outcome variable will be the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment at Day 42.

Secondary outcomes

  1. Efficacy

  2. To demonstrate a higher PANSS response rate

  3. To demonstrate superior Clinical Global Impressions (CGI) response

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Study locations

32 sites
  • Research Site
    Burgas, Bulgaria
  • Research Site
    Russe, Bulgaria
  • Research Site
    Sofia- Novi Iskar, Bulgaria
  • Research Site
    Sofia, Bulgaria
  • Research Site
    Athens, Greece
  • Research Site
    Chania, Greece
  • Research Site
    Corfu, Greece
  • Research Site
    Thessaloniki, Greece
  • Research Site
    Chennai, India
  • Research Site
    Karnataka, India
  • Research Site
    Lucknow, India
  • Research Site
    New Delhi, India
  • Research Site
    Jakarta, DKI Jakarta, Indonesia
  • Research Site
    Bandung, West Java, Indonesia
  • Research Site
    Surabaya, Indonesia
  • Research Site
    Cebu, Philippines
  • Research Site
    Davao City, Philippines
  • Research Site
    Mandaluyong City, Philippines
  • Research Site
    Manila, Philippines
  • Research Site
    Pasig, Philippines
  • Research Site
    Brasov, Romania
  • Research Site
    Bucharest, Romania
  • Research Site
    Bucuresti, Romania
  • Research Site
    Moscow, Russian Federation
  • Research Site
    St. Petersburg, Russian Federation
  • Research Site
    Johannesburg, Gauteng, South Africa
  • Research Site
    Medunsa, Pretoria, South Africa
  • Research Site
    Bloemfontein, South Africa
  • Research Site
    Ga-Rankuwa, South Africa
  • Research Site
    Johannesburg, South Africa
  • Research Site
    Lyttelton Manor, South Africa
  • Research Site
    Pretoria, South Africa
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References and documents

Publications

  • Kahn RS, Schulz SC, Palazov VD, Reyes EB, Brecher M, Svensson O, Andersson HM, Meulien D; Study 132 Investigators. Efficacy and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2007 Jun;68(6):832-42. doi: 10.4088/jcp.v68n0603. PubMed 17592906 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00206115
Lead sponsor
AstraZeneca
First posted
Sep 21, 2005
Start date
Nov 2004
Completion
Dec 2005
Last update
Jan 4, 2013

Study contacts

AstraZeneca CNS Medical Science Director, MD
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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