An Evaluation of the Safety and Efficacy of ABT-925 in Subjects With Acute Exacerbation of Schizophrenia

A Phase 2 study testing ABT-925 in people with Schizophrenia, run by Abbott at 18 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The objective of this study is to explore the safety and efficacy of ABT-925 involving patients who meet the DSM-IV-TR (Diagnostic and Statistical Manual of Medical Disorders, Fourth Edition Text Revision) criteria for an acute exacerbation of schizophrenia or schizoaffective disorder. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia
What is being tested?: ABT-925
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 156 participants
Where: 18 sitesin 3 countries
Study dates: Dec 2006to Oct 2007
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The subject has a current primary diagnosis of schizophrenia or schizoaffective disorder; specifically, an acute exacerbation with prominent "active phase" symptoms, as described in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision criteria (and confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision). Subjects with schizophrenia may belong to any of the following subtypes: paranoid, disorganized, catatonic, or undifferentiated.
The subject has a The Positive and Negative Syndrome Scale total score of greater than or equal to 60.
The subject has a score of greater than 4 ("moderate") on at least 2 out of the following 5 The Positive and Negative Syndrome Scale positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution.
The subject is between 18 and 65 years old inclusive at the time of randomization.
The subject has a reliable caregiver (if applicable) or an identified responsible (e.g., family member, social worker, nurse) who will support him/her to ensure compliance with treatment and outpatient visits. In addition, the subject must have an adequate place of residence.
The subject agrees to be hospitalized for the duration of the Taper off/Washout Period and at least the first fourteen days of the Double-blind Period.

Who cannot join

The subject has a body mass index greater than 35.
The subject has any condition that in the opinion of the investigator is likely to place him/her at an unacceptable safety risk by entering the study or by treatment with ABT-925.
The subject has a diagnosis of one or more of the following conditions: another primary Axis I disorder, including schizophreniform disorder, bipolar disorder or major depressive disorder; comorbid Axis II diagnoses, including borderline personality disorder and mental retardation. (Note: a diagnosis of depression not otherwise specified is acceptable for inclusion into the study).
The subject has a diagnosis of substance or alcohol disorder (abuse/dependence according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision criteria), excluding nicotine, within one (1) month prior to the beginning of the Screening Period, or in the opinion of the investigator, a disorder that will interfere with the conduct of the study.
The subject has a history of substance-induced psychotic disorder in the previous 6 months.
The subject has evidence suggestive of treatment-resistant schizophrenia (i.e., lack of significant clinical improvement despite adequate courses and doses of at least two different antipsychotic medications during the previous 2 years; or adequate use of clozapine indicated for treatment-resistant schizophrenia).

Show all 12Show fewer

The subject has serious violent, homicidal or suicidal ideation in the opinion of the investigator.
The subject has a screening QT interval corrected by Bazett formula interval of greater than 430 msec if male and greater than 450 msec if female.
The subject's Liver Function Tests (Aspartate aminotransferases, Alanine aminotransferase or total bilirubin levels) are not within normal limits at screening.
The subject has a diagnosis, history, or a positive serological result suggestive of liver disease including but not limited to hepatitis and Gilbert's Syndrome.
The subject has received any of the following treatments within the time periods described: mood stabilizers or antidepressants during the 30 days prior to Screening; electroconvulsive therapy during the 3 months prior to Screening; clozapine during 60 days prior to Screening.
The subject is currently receiving treatment with oral psychotropic medications or has received depot neuroleptics within one inter-injection interval.

Trial locations and contacts

18 sites in 3 countries.

Country

City, postcode or hospital

18 sites in 3 countries

United States11 sites

Site Reference ID/Investigator# 5188
Anaheim, California, 92805
Site Reference ID/Investigator# 4168
Atlanta, Georgia, 30308
Site Reference ID/Investigator# 4567
Austin, Texas, 78754
Site Reference ID/Investigator# 4176
Austin, Texas, 78756
Site Reference ID/Investigator# 4371
Bellaire, Texas, 77401
Site Reference ID/Investigator# 4539
Cerritos, California, 90703
Site Reference ID/Investigator# 4175
Garden Grove, California, 92845
Site Reference ID/Investigator# 4177
North Miami, Florida, 33161
Site Reference ID/Investigator# 4553
Pico Rivera, California, 90660
Site Reference ID/Investigator# 4173
San Diego, California, 92126
Site Reference ID/Investigator# 4565
Upland, California, 91786

Other trials in United States

Mexico4 sites

Site Reference ID/Investigator# 4305
Guadalajara, 44280
Site Reference ID/Investigator# 4304
Mexico City, CP 03740
Site Reference ID/Investigator# 4303
Mexico City, CP 14000
Site Reference ID/Investigator# 4298
Monterrey, CP 64000

Other trials in Mexico

Argentina3 sites

Site Reference ID/Investigator# 5227
Buenos Aires, CP1425
Site Reference ID/Investigator# 5226
Córdoba, X5009BIN
Site Reference ID/Investigator# 5224
La Plata, 1900

Other trials in Argentina

About this study

Official title: Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of ABT-925 in Subjects With Acute Exacerbation of Schizophrenia

Read the detailed description

To explore the safety and efficacy of ABT-925 treatment at three different doses for 6 weeks compared with placebo in subjects with a diagnosis of acute exacerbation of schizophrenia or schizoaffective disorder according to DSM-IV-TR criteria (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision).

Conditions: Schizophrenia
Being tested: ABT-925, Placebo
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABT-925Drug
PlaceboDrug

Study groups in NCT00412620
Study group	Role	What they receive
Sugar Pill	Placebo comparator	Not described Receives: Drug: Placebo
Group 1 Part 1 - ABT-925	Experimental	Not described Receives: Drug: ABT-925
Group 1 Part 2 - ABT-925	Experimental	Not described Receives: Drug: ABT-925
Group 2 - ABT-925	Experimental	Not described Receives: Drug: ABT-925

What is being measured

The primary outcome is the main question the study is designed to answer.

The Positive and Negative Syndrome Scale
The PANSS (The Positive and Negative Syndrome Scale) assesses the severity of symptoms of schizophrenia over the preceding seven days. The PANSS items are divided into positive, negative, and general psychopathology factors. The PANSS total score is the score of all 30 PANSS items taken together.
Measured: Assessed at screening and weekly from baseline through week 42/premature discontinuation

Secondary outcomes (4)

Brief Psychiatric Rating Scale
Subscale of PANSS (The Positive and Negative Syndrome Scale)
Measured: Assessed at screening and weekly from baseline through week 42/premature discontinuation
Clinical Global Impression Severity score
Assesses the overall, absolute degree of illness at any point in time (refer to the degree of illness at the time of the visit and during the week prior to the visit).
Measured: Assessed at screening and weekly from baseline through week 42/premature discontinuation
Calgary Depression Scale for Schizophrenia Total score
The CDSS (Calgary Depression Scale for Schizophrenia Total score) consists of items designed to assess the severity of symptoms of depression in the presence of schizophrenia such as depressed mood, hopelessness, guilt, and insomnia.
Measured: Assessed at screening and weekly from baseline through week 42/premature discontinuation
Negative Symptom Assessment
The NSA (Negative Symptom Assessment) is a 16-item instrument plus a one-item global rating designed to measure specific negative symptoms in schizophrenia
Measured: Assessed at screening and weekly from baseline through week 42/premature discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2006Oct 2007

First posted18 Dec 2006 (estimated)
Study startDec 2006
Primary completionOct 2007
Study completionOct 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 156 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00412620
Sponsor's protocol ID: M06-816
Status last verified: Sep 2010
First submitted: 14 Dec 2006
Last updated: 27 Apr 2011
Results posted: No
Data monitoring committee: Yes

Publications

Redden L, Rendenbach-Mueller B, Abi-Saab WM, Katz DA, Goenjian A, Robieson WZ, Wang Y, Goss SL, Greco N 4th, Saltarelli MD. A double-blind, randomized, placebo-controlled study of the dopamine D(3) receptor antagonist ABT-925 in patients with acute schizophrenia. J Clin Psychopharmacol. 2011 Apr;31(2):221-5. doi: 10.1097/JCP.0b013e31820e4818.
PubMed 21346607

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of ABT-925 in Subjects With Acute Exacerbation of Schizophrenia
ClinicalTrials.gov ID: NCT00412620
Acronym / sponsor ID: M06-816
Conditions: Schizophrenia
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 156 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Dec 2006
Primary completion: Oct 2007 (actual)
Study completion: Oct 2007 (actual)
First posted: 18 Dec 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Sugar Pill	Placebo comparator	Drug: Placebo
Group 1 Part 1 - ABT-925	Experimental	Drug: ABT-925
Group 1 Part 2 - ABT-925	Experimental	Drug: ABT-925
Group 2 - ABT-925	Experimental	Drug: ABT-925

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

The subject has a current primary diagnosis of schizophrenia or schizoaffective disorder; specifically, an acute exacerbation with prominent "active phase" symptoms, as described in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision criteria (and confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision). Subjects with schizophrenia may belong to any of the following subtypes: paranoid, disorganized, catatonic, or undifferentiated.
The subject has a The Positive and Negative Syndrome Scale total score of greater than or equal to 60.
The subject has a score of greater than 4 ("moderate") on at least 2 out of the following 5 The Positive and Negative Syndrome Scale positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution.
The subject is between 18 and 65 years old inclusive at the time of randomization.
The subject has a reliable caregiver (if applicable) or an identified responsible (e.g., family member, social worker, nurse) who will support him/her to ensure compliance with treatment and outpatient visits. In addition, the subject must have an adequate place of residence.

Key exclusion criteria (12 listed)

The subject has a body mass index greater than 35.
The subject has any condition that in the opinion of the investigator is likely to place him/her at an unacceptable safety risk by entering the study or by treatment with ABT-925.
The subject has a diagnosis of one or more of the following conditions: another primary Axis I disorder, including schizophreniform disorder, bipolar disorder or major depressive disorder; comorbid Axis II diagnoses, including borderline personality disorder and mental retardation. (Note: a diagnosis of depression not otherwise specified is acceptable for inclusion into the study).
The subject has a diagnosis of substance or alcohol disorder (abuse/dependence according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision criteria), excluding nicotine, within one (1) month prior to the beginning of the Screening Period, or in the opinion of the investigator, a disorder that will interfere with the conduct of the study.
The subject has a history of substance-induced psychotic disorder in the previous 6 months.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ABT-925	Drug	Group 1 Part 1 - ABT-925, Group 1 Part 2 - ABT-925, Group 2 - ABT-925
Placebo	Drug	Sugar Pill

Primary outcome

The Positive and Negative Syndrome Scale
Time frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation
The PANSS (The Positive and Negative Syndrome Scale) assesses the severity of symptoms of schizophrenia over the preceding seven days. The PANSS items are divided into positive, negative, and general psychopathology factors. The PANSS total score is the score of all 30 PANSS items taken together.

4 secondary outcomes

Brief Psychiatric Rating Scale
Time frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation
Clinical Global Impression Severity score
Time frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation
Calgary Depression Scale for Schizophrenia Total score
Time frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation
Negative Symptom Assessment
Time frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2011.
Derived from this study: PubMed 21346607Redden L, Rendenbach-Mueller B, Abi-Saab WM, Katz DA, Goenjian A, Robieson WZ, Wang Y, Goss SL, Greco N 4th, Saltarelli MD. A double-blind, randomized, placebo-controlled study of the dopamine D(3) receptor antagonist ABT-925 in patients with acute schizophrenia. J Clin Psychopharmacol. 2011 Apr;31(2):221-5. doi: 10.1097/JCP.0b013e31820e4818.

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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Beatrice Rendenbach-Mueller, PhD study director

Abbott

18 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-925 in people with Schizophrenia, run by Abbott at 18 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Mexico, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Positive and Negative Syndrome Scale (time frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00412620, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2011; AzTrials last refreshed its copy on 8 Nov 2026.