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20101299: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms

Sponsor
Amgen (Industry)
Overall Status
Terminated
CT.gov ID
NCT01568216
Collaborator
(none)
121
Enrollment
38
Locations
4
Arms
13
Duration (Months)
3.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in period on their current antipsychotic treatment, patients will be randomized to one of the four treatment arms as add-on therapy for a treatment duration of up to 3 months.

Condition or Disease Intervention/Treatment Phase
  • Drug: AMG 747
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
121 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
"A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms"
Study Start Date :
May 1, 2012
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: AMG 747 - Dose 1

Drug: AMG 747
Three dose levels once-daily oral administration
Experimental: AMG 747 - Dose 2

Drug: AMG 747
Three dose levels once-daily oral administration
Experimental: AMG 747 - Dose 3

Drug: AMG 747
Three dose levels once-daily oral administration
Placebo Comparator: Placebo Comparator

Drug: Placebo
Once-daily oral administration

Outcome Measures

Primary Outcome Measures

  1. Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score [12 Weeks]

    NSA-16 = 16-item Negative Symptom Assessment Scale, an efficacy scale used for the primary endpoint

Secondary Outcome Measures

  1. Response defined as a ≥ 20% decrease in the NSA-16 total score at week 12 [12 weeks]

    NSA-16 = 16-item Negative Symptom Assessment Scale

  2. Change from baseline to week 12 on the PANSS total score and Marder factor scores [12 weeks]

    Positive and Negative Syndrome Scale (PANSS)

  3. Change from baseline to week 12 on the CGI-S [Week 12]

    Clinical Global Impression Severity Scale (CGI-S)

  4. CGI-I scores at week 12 [12 weeks]

    Clinical Global Impression Improvement (CGI-I)

  5. Change on cognition battery [12 weeks]

  6. Change in personal and social functioning [12 weeks]

  7. Change on patient reported outcomes [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) schizophrenia

  • Total score on the PANSS Marder Negative Symptom Factor Scale (NSFS) ≥20

  • Total score on the PANSS Marder Positive Symptom Factor Scale (PSFS) ≤ 30

  • Receiving stable antipsychotic therapy for at least 8 weeks prior to screening

  • Receiving a stable dose of other psychotropic agents for at least 8 weeks prior to screening

  • Subject has had a stable residence or living arrangement for at least 8 weeks prior to screening and the residence or living arrangement is not anticipated to change for the duration of the study

  • The subject or subject's legally acceptable representative has provided informed consent.

Exclusion Criteria:

  • Current schizoaffective or bipolar disorder, panic disorder, obsessive compulsive disorder, evidence of mental retardation by history or clinical examination or known premorbid IQ ≤ 70

  • Clinically significant suicidal ideation or suicide attempts, assaultive behavior or marked changes in mood within the 8 weeks prior to screening, or currently endorsing suicidal ideation in clinical exam

  • Substance abuse (with the exception of nicotine or caffeine abuse) within the 8 weeks prior to screening, or during screening

  • Substance dependence (with the exception of nicotine or caffeine dependence) within the 6 months prior to screening, or during screening

  • Planning to initiate a smoking cessation therapy or otherwise substantially modify nicotine use during the study

  • Positive urine drug test for substances of abuse (with the exception of positive screens for prescribed agents such as benzodiazepines).

  • Other criteria may apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Anaheim California United States 92804
2 Research Site Cerritos California United States 90703
3 Research Site Culver City California United States 90230
4 Research Site Garden Grove California United States 92845
5 Research Site Los Angeles California United States 90073
6 Research Site Norwalk California United States 90650
7 Research Site San Bernardino California United States 92408
8 Research Site Torrance California United States 90502
9 Research Site Washington District of Columbia United States 20016
10 Research Site North Miami Florida United States 33161
11 Research Site Atlanta Georgia United States 30308
12 Research Site Chicago Illinois United States 60640
13 Research Site Marlton New Jersey United States 08053
14 Research Site Glen Oaks New York United States 11004
15 Research Site Rochester New York United States 14618
16 Research Site Raleigh North Carolina United States 27603
17 Research Site Dayton Ohio United States 45417
18 Research Site Houston Texas United States 77008
19 Research Site Glenside South Australia Australia 5065
20 Research Site Melbourne Victoria Australia 3004
21 Research Site Mt Claremont Western Australia Australia 6010
22 Research Site Calgary Alberta Canada T2N 4Z6
23 Research Site Penticton British Columbia Canada V2A 4M4
24 Research Site Kingston Ontario Canada K7L 4X3
25 Research Site Montreal Quebec Canada H3A 1A1
26 Research Site Takapuna, Auckland New Zealand 1309
27 Research Site Khotkovo Russian Federation 141371
28 Research Site Moscow Russian Federation 107076
29 Research Site Moscow Russian Federation 115552
30 Research Site Saint- Petersburg Russian Federation 192019
31 Research Site Saratov Russian Federation 410028
32 Research Site Singapore Singapore 539747
33 Research Site Santander Cantabria Spain 39008
34 Research Site Barcelona Cataluña Spain 08036
35 Research Site Cornellá de Llobregat Cataluña Spain 08940
36 Research Site L'Hospitalet de Llobregat Cataluña Spain 08907
37 Research Site Valencia Comunidad Valenciana Spain 46010
38 Research Site Madrid Spain 28009

Sponsors and Collaborators

  • Amgen

Investigators

  • Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT01568216
Other Study ID Numbers:
  • 20101299
  • 2011-004844-23
First Posted:
Apr 2, 2012
Last Update Posted:
Jul 30, 2015
Last Verified:
Jul 1, 2015
Keywords provided by Amgen
schizophrenia negative symptoms
Additional relevant MeSH terms:
Schizophrenia

Study Results

No Results Posted as of Jul 30, 2015