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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00888693
First Posted: April 28, 2009
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AbbVie
  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 (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Physical Exams, Brief Neurological Exams, Vitals, Orthostatic Vitals, ECG, Laboratory tests, [ Time Frame: Days -1 to 21 ]
  • Pharmacokinetics; optional CSF for arms 7, 8 & 9 [ Time Frame: Days -1 to 21 ]

Secondary Outcome Measures:
  • Extrapyramidal Symptom Rating Scale [ Time Frame: Day -1, Day 14 ]
  • Columbia Suicide Severity Rating Scale [ Time Frame: Screening, Day 15 ]
  • Pharmacodynamics: CANTAB & PANSS [ Time Frame: Screening, Day -1, Day 14 ]
  • Pharmacodynamics: Pittsburgh Sleep Quality Index-Modified [ Time Frame: Day -1, Day 15 ]

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.
Drug: Placebo
See Arm Description for details.
Experimental: 2
ABT-288 vs placebo capsules administered orally once daily for 14 days
Drug: ABT-288
See Arm Description for details.
Drug: Placebo
See Arm Description for details.
Experimental: 3
ABT-288 vs placebo capsules administered orally once daily for 14 days
Drug: ABT-288
See Arm Description for details.
Drug: Placebo
See Arm Description for details.
Experimental: 4
ABT288 vs placebo administered orally once daily for 14 days
Drug: ABT-288
See Arm Description for details.
Drug: Placebo
See Arm Description for details.
Experimental: 5
ABT-288 vs placebo administered orally once daily for 14 days
Drug: ABT-288
See Arm Description for details.
Drug: Placebo
See Arm Description for details.
Experimental: 6
ABT-288 vs placebo administered orally once daily for 14 days
Drug: ABT-288
See Arm Description for details.
Drug: Placebo
See Arm Description for details.
Experimental: 7
ABT-288 vs placebo administered orally once daily for 14 days
Drug: ABT-288
See Arm Description for details.
Drug: Placebo
See Arm Description for details.
Experimental: 8
ABT-288 vs placebo administered orally once daily for 14 days
Drug: ABT-288
See Arm Description for details.
Drug: Placebo
See Arm Description for details.
Experimental: 9
ABT-288 vs placebo administered orally once daily for 14 days
Drug: ABT-288
See Arm Description for details.
Drug: Placebo
See Arm Description for details.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Hana Florian, MD/Associate Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00888693     History of Changes
Other Study ID Numbers: M10-752
First Submitted: April 27, 2009
First Posted: April 28, 2009
Last Update Posted: November 21, 2017
Last Verified: October 2010

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders