Clinical trial NCT00198198: Aripiprazole Treatment of Bipolar Depression
Official title: Open Label Pilot Study of Aripiprazole Treatment of Difficult to Treat Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Depression
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study of addition of aripirazole to the treatment of bipolar depressed patients who are not better on the medications that they are currently receiving.

Detailed description: Hypothesis/Objectives:

Aim 1: To investigate whether aripiprazole is effective in the treatment of bipolar depression.

Hypothesis 1: Aripiprazole will lead to a significant decrease in scores on the Hamilton Depression Rating Scale (HAM-D) during an 8-week treatment course.

a. Study Population:

A total number of 10 evaluable patients will be enrolled in the study.

c. Study Design and Method

This proposal will use an open label design. Aripiprazole will be added to the treatment of patients with DSM-IV (American Psychiatric Association, 1994) BDD. Patients will be allowed to continue their psychotropic medication, at a stable dose, as long as they meet inclusion criteria as described below. Aripiprazole will be started at a dose of 10 mg for two weeks, 15 mg for an additional two weeks, and 20 mg for the last four weeks. The length of time a patient stays on the maximum dose (20 mg) depends upon the patient's tolerance and treatment response. Treatment will continue for 8 weeks with weekly visits and ratings on the 17-item Hamilton Depression Rating Scale (HAM-D 17) and other ratings scales.

Eligibility criteria: Inclusion Criteria:

* 1) Male or female between 18 - 65 years of age, inclusive 2) Satisfy DSM-IV criteria for bipolar disorder depressed phase i.e.,duration of depression \> 2 weeks) 3) No change in psychotropic medication or their doses within 2 weeks of inclusion in The study. 4) Inadequately responsive to or intolerant of prior pharmacotherapy as determined by the investigator 5) 17-item Hamilton Depression Rating Scale Score \> 15 6) Young Mania Rating Scale (Young, et. al., 1978) (YMRS) \< 10.

Exclusion Criteria:

Exclusion Criteria: 1) History of or currently suffering from serious medical illness, or be on medication that may interact with aripiprazole 2) On any other neuroleptic e.g., olanzapine, risperidone, ziprasidone, haloperidol.

3) History of substance abuse within 3 months or substance dependence within 6 months of the study. 4) Pregnant or planning to be pregnant or not using adequate contraception. 5) Received electroconvulsive therapy (ECT) treatment in the past 1 year. 6) Significant suicide or homicide risk at the time of the study; 7) Not on any herbal or any other alternative pharmacological treatment. 8) Renal or hepatic dysfunction 9) History of decreased sweating or heat stroke.

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Primary outcomes:
measure: Hamilton Depression Scale
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: UH 3124 University Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Amit Anand, MD
role: PRINCIPAL_INVESTIGATOR
References: