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OpenTrials
Completed

NCT Number: NCT00888693

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABT-288

Drug

See Arm Description for details.

Placebo

Drug

See Arm Description for details.

Primary outcomes

  1. Physical Exams, Brief Neurological Exams, Vitals, Orthostatic Vitals, ECG, Laboratory tests,

    Time frame: Days -1 to 21

  2. Pharmacokinetics; optional CSF for arms 7, 8 & 9

    Time frame: Days -1 to 21

Secondary outcomes

  1. Extrapyramidal Symptom Rating Scale

    Time frame: Day -1, Day 14

  2. Columbia Suicide Severity Rating Scale

    Time frame: Screening, Day 15

  3. Pharmacodynamics: CANTAB & PANSS

    Time frame: Screening, Day -1, Day 14

  4. Pharmacodynamics: Pittsburgh Sleep Quality Index-Modified

    Time frame: Day -1, Day 15

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
First posted
Apr 28, 2009
Registry last updated
Nov 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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