NCT00810667

Brief Summary

The objective of this study is to explore the efficacy, safety and cognitive properties of Lu AE58054 as augmentation therapy to risperidone in patients with schizophrenia.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for phase_2 schizophrenia

Timeline
Completed

Started Nov 2008

Geographic Reach
8 countries

25 active sites

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

Study Start

First participant enrolled

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

December 17, 2008

Last Update Submit

November 7, 2016

Conditions

SchizophreniaCognition

Keywords

SchizophreniaCognitionBACSRisperidoneAugmentation therapyAdd-on therapyLu AE58054

Outcome Measures

Primary Outcomes (1)

  • Efficacy effect of treatment based on the PANSS total score

    12 weeks

Secondary Outcomes (1)

  • PANSS subscales scores, CGI-S and CGI-I scores, CDSS scores, S-QoL scores, BACS, Abnormal movement scales (AIMS, BARS, SAS), ECGs, serum prolactin, pharmacokinetic assessments

    12 weeks

Study Arms (2)

Lu AE58054

EXPERIMENTAL
Drug: Lu AE58054

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Lu AE58054DRUG

twice daily oral dose (60 mg BID: total dose 120 mg/day)

Lu AE58054
PlaceboDRUG

twice daily oral dose

Placebo

Eligibility Criteria

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

You may qualify if:

  • Primary diagnosis of schizophrenia
  • Man or woman, aged between 18-65
  • Patient is on an optimised dose of risperidone (within 4-8 mg/day) for the treatment of schizophrenia for a minimum of 4 weeks prior to screening
  • The patient has a PANSS total score between 70 and 100 (extremes included) at screening

You may not qualify if:

  • Primary psychiatric diagnosis other than schizophrenia
  • Acute exacerbation requiring hospitalisation within the last 3 months
  • Clinically significant extrapyramidal symptoms
  • Clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia
  • Significant ECG abnormalities
  • In concurrent treatment with drugs inhibiting the P450 enzymes system CYP2D6 and other CYP Isozymes
  • Failed to respond to adequate courses of treatment with risperidone
  • Treated with an antipsychotic other than risperidone within 4 weeks prior to screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

BE001

Liège, 4000, Belgium

Location

BE005

Liège, 4000, Belgium

Location

FR002

Bordeaux, 33076, France

Location

FR003

Brumath, 67170, France

Location

FR001

Nîmes, 30029, France

Location

FR006

Toulouse, 31059, France

Location

DE002

Dresden, 1307, Germany

Location

HK001

Hong Kong, Hong Kong

Location

IT003

Brescia, Italy

Location

IT004

Napoli, Italy

Location

PL009

Bełchatów, 97-400, Poland

Location

PL006

Bialystok, 15 617, Poland

Location

PL002

Leszno, 64 100, Poland

Location

PL012

Lodz, 91-229, Poland

Location

PL003

Lublin, 20 080, Poland

Location

PL001

Lublin, 20 442, Poland

Location

PL010

Piekary Śląskie, 41-940, Poland

Location

PL004

Skorzewo, 60 185, Poland

Location

PL008

Torun, 87-100, Poland

Location

PL011

Warsaw, 02-791, Poland

Location

PL007

Września, 62 300, Poland

Location

TW001

Hualien City, 98142, Taiwan

Location

TW003

Keelung, 204, Taiwan

Location

TW004

Tainan, 704, Taiwan

Location

TH002

Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

(2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 18, 2008

Study Start

November 1, 2008

Primary Completion

January 1, 2010

Study Completion

February 1, 2010

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations

HK(1)FR(4)IT(2)TH(1)TW(3)DE(1)BE(2)PL(11)