A Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00888693
First received: April 27, 2009
Last updated: December 5, 2010
Last verified: October 2010
  Purpose

Evaluate the safety, tolerability and pharmacokinetics of ABT-288 in order to determine the maximum tolerated dose of ABT-288 in stable schizophrenic volunteers receiving treatment with an atypical antipsychotic.


Condition Intervention Phase
Schizophrenia
Drug: ABT-288
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Physical Exams, Brief Neurological Exams, Vitals, Orthostatic Vitals, ECG, Laboratory tests, [ Time Frame: Days -1 to 21 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics; optional CSF for arms 7, 8 & 9 [ Time Frame: Days -1 to 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Extrapyramidal Symptom Rating Scale [ Time Frame: Day -1, Day 14 ] [ Designated as safety issue: Yes ]
  • Columbia Suicide Severity Rating Scale [ Time Frame: Screening, Day 15 ] [ Designated as safety issue: Yes ]
  • Pharmacodynamics: CANTAB & PANSS [ Time Frame: Screening, Day -1, Day 14 ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Pittsburgh Sleep Quality Index-Modified [ Time Frame: Day -1, Day 15 ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: November 2008
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ABT-288 vs placebo capsules administered orally once daily for 14 days
Drug: ABT-288
See Arm Description for details.
Other Name: ABT-288
Drug: Placebo
See Arm Description for details.
Other Name: Placebo
Experimental: 2
ABT-288 vs placebo capsules administered orally once daily for 14 days
Drug: ABT-288
See Arm Description for details.
Other Name: ABT-288
Drug: Placebo
See Arm Description for details.
Other Name: Placebo
Experimental: 3
ABT-288 vs placebo capsules administered orally once daily for 14 days
Drug: ABT-288
See Arm Description for details.
Other Name: ABT-288
Drug: Placebo
See Arm Description for details.
Other Name: Placebo
Experimental: 4
ABT288 vs placebo administered orally once daily for 14 days
Drug: ABT-288
See Arm Description for details.
Other Name: ABT-288
Drug: Placebo
See Arm Description for details.
Other Name: Placebo
Experimental: 5
ABT-288 vs placebo administered orally once daily for 14 days
Drug: ABT-288
See Arm Description for details.
Other Name: ABT-288
Drug: Placebo
See Arm Description for details.
Other Name: Placebo
Experimental: 6
ABT-288 vs placebo administered orally once daily for 14 days
Drug: ABT-288
See Arm Description for details.
Other Name: ABT-288
Drug: Placebo
See Arm Description for details.
Other Name: Placebo
Experimental: 7
ABT-288 vs placebo administered orally once daily for 14 days
Drug: ABT-288
See Arm Description for details.
Other Name: ABT-288
Drug: Placebo
See Arm Description for details.
Other Name: Placebo
Experimental: 8
ABT-288 vs placebo administered orally once daily for 14 days
Drug: ABT-288
See Arm Description for details.
Other Name: ABT-288
Drug: Placebo
See Arm Description for details.
Other Name: Placebo
Experimental: 9
ABT-288 vs placebo administered orally once daily for 14 days
Drug: ABT-288
See Arm Description for details.
Other Name: ABT-288
Drug: Placebo
See Arm Description for details.
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has signed informed consent;
  • Current DSM-IV-TR diagnosis of schizophrenia;
  • Clinically stable on the same single second-generation antipsychotic for the past 8 weeks;
  • Meets study-specific PANSS criteria;
  • Willing and able to cooperate with cognitive testing
  • Females are not pregnant, not breast-feeding;
  • Females are post-menopausal or surgically sterile or practicing birth control;
  • Males are surgically sterile or agree to be sexually inactive or use barrier method of birth control

Exclusion Criteria:

  • Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
  • Diagnosis of schizoaffective disorder;
  • Bipolar disorder, manic episode, dementia, OCD, or drug-induced psychosis or current major depressive disorder;
  • Diagnoses with mental retardation; acute psychosis hospitalization within past 6 months;
  • Current clozapine treatment; suicidal ideation or behavior;
  • BMI of 39 or greater; current homicidal or violent ideation;
  • Medical or CNS condition other than schizophrenia that could affect cognitive performance or testing; relevant drug sensitivity or allergy; positive urine screen for alcohol or drugs of abuse;
  • Positive hepatitis or HIV test result;
  • Recent clinically significant illness/infection or surgery;
  • Recent blood product transfusion, donation or loss of 5 mL/kg of blood;
  • Visual, hearing or communication disability
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888693

Locations
United States, California
Site Reference ID/Investigator# 15143
Glendale, California, United States, 91206
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Hana Florian, MD/Associate Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00888693     History of Changes
Other Study ID Numbers: M10-752
Study First Received: April 27, 2009
Last Updated: December 5, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014