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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00541554
Other study ID # 31-06-P05
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received October 8, 2007
Last updated October 9, 2007
Start date October 2007
Est. completion date February 2009

Study information

Verified date October 2007
Source Genovate Biotechnology Co., Ltd.,
Contact Chen Chih-Ken, PhD
Phone +886-2-24313131
Email kenchen@cgmh.org.tw
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 0
Est. completion date February 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 65 Years
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Abilify (aripiprazole)


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Genovate Biotechnology Co., Ltd.,
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