Reversal of Antipsychotic-Induced Hyperprolactinemia, Weight Gain, Hyperglycemia and Dyslipidemia - Full Text View

Sponsored by:	Genovate Biotechnology Co., Ltd.,
Information provided by:	Genovate Biotechnology Co., Ltd.,
ClinicalTrials.gov Identifier:	NCT00541554

Purpose

This is a prospective, open-label study to evaluate the efficacy and safety in reducing antipsychotic-induced hyperprolactinemia, weight gain, and dyslipidemia by aripiprazole. Approximate 60 patients will be recruited to achieve at least 40 evaluable patients.

Condition	Intervention	Phase
Hyperprolactinemia Weight Gain Dyslipidemia	Drug: Abilify (aripiprazole)	Phase IV

Drug Information available for: Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Reversal of Antipsychotic-Induced Hyperprolactinemia, Weight Gain, Hyperglycemia and Dyslipidemia by Aripiprazole Add-on Therapy in the Treatment of Schizophrenia and Bipolar Disorder: An Open-Label Trial

Further study details as provided by Genovate Biotechnology Co., Ltd.,:

Study Start Date:	October 2007
Estimated Study Completion Date:	February 2009

Detailed Description:

A.Screening / Baseline visit (V1; Day 0) After signing the informed consent form, patients' DSM-IV multiaxial examination, physical examination, vital sign, pregnancy test, BMI will be conducted. The demographics, medical history, and concomitant medication will be recorded. After evaluating all variables obtained, the eligible patients will be enrolled into study.Patients who fulfill the inclusion / exclusion criteria will be performed the laboratory tests, PANSS, EPS (AIMS & BARS), menstrual function, sexual function (Arizona sexual experience scale) and prolaction. Afterwards, the treatment period will be started to add-on with first medication (7.5 or 15 mg daily by patient, which was prescribed by investigator) to current antipsychotics at this visit. Besides, drug accounting and adverse events will also be recorded at this visit. Patients are maintained on current doses of antipsychotics, and all other medicines.

B.Treatment phase (V2~V3; 2~4 Week finished; 14±3~28±3 Day finished) The vital sign, physical examination, BMI, laboratory tests (at V3), PANSS, EPS (AIMS & BARS), menstrual function, sexual function (Arizona sexual experience scale), and prolactin will be carried out. Concomitant medication, adverse events, and drug accounting will also be recorded at this visit. Study drug could be titrated with a flexible dose from 7.5 to 30 mg QD. All dose adjustments should be made with the approval of the investigator.

C.Completion visit (V4; 8 Week Finished; 56±7 Day finished, or Early termination) The vital sign, physical examination, pregnancy test, BMI, laboratory tests, PANSS, EPS (AIMS & BARS), menstrual function, sexual function (Arizona sexual experience scale), prolactin will be carried out. Concomitant medication, adverse events, and drug accounting will also be recorded at this visit.

Eligibility

Ages Eligible for Study:	12 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female in age between 12 and 65 years old.
Clinical diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder with DSM-IV criteria.
Keep stable dosage of the same antipsychotic other than aripiprazole during last one month.
Who are currently taking antipsychotic drugs and for whom an alteration in medication is clinically reasonable. This includes patients who are stable or who have symptoms that are not optimally controlled or patients experiencing tolerability problems.
Having antipsychotic-induced symptomatic hyperprolactinemia, weight gain, increased plasma glucose or dyslipidemia judged by the investigator.
Informed Consent was obtained from the subject and legal guardian (if necessary).

Exclusion Criteria:

Pregnant or breast feeding women or planning a pregnancy.
Patient has a history of hypersensitivity or allergy to investigated drug.
Acute psychosis, acute suicidal ideation, or any acute psychiatric condition that might require emergent intervention.
Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
Having participated other investigational drug study and taken the investigation drug within one month prior to study entry.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541554

Contacts

Contact: Chen Chih-Ken, PhD

+886-2-24313131 ext 3150

kenchen@cgmh.org.tw

Sponsors and Collaborators

Genovate Biotechnology Co., Ltd.,

Investigators

Principal Investigator:

Chen Chih-Ken, PhD

Chang Gung Memorial Hospital, Keelung, Taiwan

More Information

Study ID Numbers:	31-06-P05
Study First Received:	October 8, 2007
Last Updated:	October 9, 2007
ClinicalTrials.gov Identifier:	NCT00541554
Health Authority:	Taiwan: Institutional Review Board

Study placed in the following topic categories:

Hypothalamic Diseases
Metabolic Diseases
Pituitary Diseases
Bipolar Disorder
Endocrine System Diseases
Central Nervous System Diseases
Weight Gain
Brain Diseases
Body Weight
Schizophrenia
Signs and Symptoms

Hyperglycemia
Galactorrhoea-Hyperprolactinaemia
Body Weight Changes
Hyperprolactinemia
Aripiprazole
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Tranquilizing Agents
Hyperpituitarism
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases

Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009