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
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 April 16, 2014