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

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:

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

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 May 16, 2013