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

October 9, 2007 updated by: Genovate Biotechnology Co., Ltd.,

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 63 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genovate Biotechnology Co., Ltd.,

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Study Completion (Anticipated)

February 1, 2009

Study Registration Dates

First Submitted

October 8, 2007

First Submitted That Met QC Criteria

October 9, 2007

First Posted (Estimate)

October 10, 2007

Study Record Updates

Last Update Posted (Estimate)

October 10, 2007

Last Update Submitted That Met QC Criteria

October 9, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31-06-P05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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