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

• Status: Unknown status
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genovate Biotechnology Co., Ltd.,
• Treatments: Antipsychotic Agents; Aripiprazole

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.