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

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Brief Title

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

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

Brief Summary

      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.
    

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.
    

Study Phase

Phase 4

Study Type

Interventional




Condition

Hyperprolactinemia

Intervention

Abilify (aripiprazole)


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug


Start Date

October 2007

Completion Date

February 2009


Eligibility 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.
      

Gender

All

Ages

12 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Chen Chih-Ken, PhD, +886-2-24313131, [email protected]



Administrative Informations


NCT ID

NCT00541554

Organization ID

31-06-P05



Study Sponsor

Genovate Biotechnology Co., Ltd.,


Study Sponsor

Chen Chih-Ken, PhD, Principal Investigator, Chang Gung Memorial Hospital, Keelung, Taiwan


Verification Date

October 2007