Aripiprazole as Augmentation for TRD

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

A sizeable minority of patients suffering from major depression do not have their full set of depressive symptoms relieved by a single medication. Often times, a second medication is added to a patient's first antidepressant to obtain a better response in hopes of getting the depressed patient into full remission from symptoms.

A typical psychiatric approach of recent has been to add one of the newer anti-schizophrenia medications to an existing FDA approved antidepressant in order to achieve better serotonin levels in the depressed patient's brain. This optimization of brain serotonin helps to alleviate more depressive symptoms. The newest antipsychotic medication to be FDA approved is Aripiprazole (Abilify). It may be particularly effective as it may safely elevate sertotonin through receptor 1a stimulation, receptor 2a blockade. It may also facilitate low levels of dopamine transmission which is truly novel for this agent when compared to other schizophrenia drugs. Depressed patients also tend to lack dopamine in their brains. This makes Aripiprazole and ideal agent to boost both serotonin and dopamine simultaneously. In theory, this may be an effective way to alleviate more depressive symptoms.

The author suggests to enroll 10 subjects initially in open label fashion to take Aripiprazole plus their current FDA approved antidepressant to see if further elimination of depressive symptoms occurs and to show this pharmacological approach as a tolerable combination of medications. If there are no major safety issues, an amendment to allow 10 additional subjects will be forwarded to provide a better tolerability sample size.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: State University of New York - Upstate Medical University
• Collaborator: Bristol-Myers Squibb
• Treatments: Aripiprazole

Criteria

Inclusion Criteria:

• Inclusion Criteria: males or females age 18 to 65 years, DSM-IV episode of Major Depression non-psychotic, ≥14 score on the 17-item HRSD, adequate trial with two antidepressants (see definition above of 'adequate trial'), ability to receive and give informed consent, if patients are of child-bearing potential (male or female), use of an effective contraceptive is required for at least one month prior to the screening Visit and documentation of a negative pregnancy (female) test upon entry into the study.

Exclusion Criteria:

• Exclusion Criteria: bipolar or psychotic depression, overt personality disorder, currently suicidal or a history of suicide attempt in the previous 6 months, current substance abuse or history of substance abuse in the previous 12 months, history of hypersensitivity to aripiprazole, treatment with antipsychotic medications in the previous 3 months, serious or unstable medical disorders which in and amongst themselves may lend to morbidity or mortality during study, any medical illness with relative contraindication for aripiprazole use, starting or terminating psychotherapy during the previous 12 weeks, ECT treatment in the previous 3 months, pregnancy or planning pregnancy, history of severe head injury with sequelae, comorbid anxiety condition which has been focus of clinical attention in previous 6 months (remitted GAD, OCD, Panic, Social Anxiety, PTSD may be allowed).