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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Genovate Biotechnology Co., Ltd.,.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Genovate Biotechnology Co., Ltd.,
ClinicalTrials.gov Identifier:
NCT00541554
First received: October 8, 2007
Last updated: October 9, 2007
Last verified: October 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

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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:

  1. Male or female in age between 12 and 65 years old.
  2. Clinical diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder with DSM-IV criteria.
  3. Keep stable dosage of the same antipsychotic other than aripiprazole during last one month.
  4. 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.
  5. Having antipsychotic-induced symptomatic hyperprolactinemia, weight gain, increased plasma glucose or dyslipidemia judged by the investigator.
  6. Informed Consent was obtained from the subject and legal guardian (if necessary).

Exclusion Criteria:

  1. Pregnant or breast feeding women or planning a pregnancy.
  2. Patient has a history of hypersensitivity or allergy to investigated drug.
  3. Acute psychosis, acute suicidal ideation, or any acute psychiatric condition that might require emergent intervention.
  4. Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
  5. Having participated other investigational drug study and taken the investigation drug within one month prior to study entry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Genovate Biotechnology Co., Ltd.,

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00541554     History of Changes
Other Study ID Numbers: 31-06-P05
Study First Received: October 8, 2007
Last Updated: October 9, 2007
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Hyperglycemia
Hyperprolactinemia
Weight Gain
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Lipid Metabolism Disorders
Antipsychotic Agents
Aripiprazole
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 22, 2014