ClinicalTrials.Veeva

Menu

A Phase 2 Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia

AbbVie logo

AbbVie

Status and phase

Completed
Phase 2

Conditions

Schizophrenia

Treatments

Drug: ABT-126
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01678755
M13-608

Details and patient eligibility

About

This is an efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.

Full description

Safety and Efficacy Study for Cognitive Deficits in Adult Subjects with Schizophrenia.

Enrollment

157 patients

Sex

All

Ages

20 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Has a current Diagnostic and Statistical Manual of Mental Disorders-, 4th Edition, Text Revision (DSM-IV-TR) diagnosis of schizophrenia confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.).
  • Is clinically stable while receiving a regimen of one or two allowable antipsychotic medications; lack of hospitalizations in 4 months prior to initial screening visit; taking the same antipsychotic medication(s) for at least 8 weeks prior to baseline visit; core positive symptoms of Positive and Negative Syndrome Scale (PANSS) no worse than moderate in severity throughout screening period of at least 4 weeks.
  • Has been diagnosed with or treated for schizophrenia for at least 2 years prior to initial screening visit.
  • Has had continuity in psychiatric care (e.g., mental health system, clinic or physician) for at least 6 months prior to initial screening visit.
  • Has an identified contact person (e.g., family member, social worker, case worker, or nurse) that can provide support to the subject to ensure compliance with protocol requirements.

Exclusion criteria

  • In the Investigator's judgment, has a current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, post traumatic stress disorder, or obsessive-compulsive disorder, or the subject has a current major depressive episode.
  • Has a positive urine drug screen for cocaine, phencyclidine (PCP), opiates (unless duly prescribed), benzodiazepines (unless duly prescribed), marijuana, or amphetamines during the Screening Period.
  • Has a current or past history of seizures, with the exception of a single febrile seizure occurring prior to 6 years of age.
  • Has a clinically significant abnormal electrocardiogram (ECG) at Screening Visit 1 as determined by the Investigator.
  • Has any risk factors for Torsades de Pointes (TdP)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

157 participants in 3 patient groups, including a placebo group

ABT-126 Low Dose
Experimental group
Description:
ABT-126 Low Dose
Treatment:
Drug: ABT-126
Drug: ABT-126
ABT-126 High Dose
Experimental group
Description:
ABT-126 High Dose
Treatment:
Drug: ABT-126
Drug: ABT-126
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

20

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems