Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174876
Status:
COMPLETED
Last Update Posted:
2008-09-18
First Post:
2005-09-09
Brief Title:
Aripiprazole as Augmentation for TRD
Sponsor:
State University of New York - Upstate Medical University
Organization:
State University of New York - Upstate Medical University
Study Overview
Official Title:
An Open-Label Study of Aripiprazole Abilify as an Augmentation Agent in Patients With Treatment-Resistant Depression
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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 patients 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
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 patients 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
Detailed Description:
This is a prospective open-label study that will examine the clinical utility and safety of adding the atypical antipsychotic aripiprazole as an augmenting agent to antidepressant therapy in treatment-resistant depressed patients The authors a priori hypothesis is that aripiprazole plus a current FDA approved antidepressant will result in significant reductions in depressive symptoms over 6 weeks Responders 50 improvement in baseline HAM-D score will be asked to voluntarily continue in a 6 week open-label extension in order to show that antidepressant effects of aripiprazole are longstanding in nature
After screening and consenting and liaison with a primary prescriber 10 eligible subjects will receive aripiprazole 10-30 mg per day as an augmentation agent in combination with their current FDA approved antidepressant medication The dose of the subjects original antidepressant will remain unchanged during the study unless subject notes intolerable newly emergent antidepressant-related side effects Based on tolerability and response aripiprazole will be started at 5 mg per day and augmented as follows baseline end of week 1 end of week 2 end of week 4 and termination visit end of week 6 at 5 mg per day increments the maximum dose being 30 mg per day for patients who are taking antidepressants that have no pre-existing significant inhibitory effect on CYP450 2D6 enzyme system However if the patient is taking any antidepressant that has significant CYP450 2D6 enzyme inhibitory properties that may affect the metabolism of aripiprazole eg paroxetine fluoxetine the maximum dose will be 15 mg per day 50 less than the maximum recommended dose These dose ranges have been chosen because they capture the mean effective dose for ameliorating depressive symptoms in schizophrenia The dose will be titrated upward or downward based on clinical response Other psychotropic medications will be permitted during the study if deemed necessary to control side effects hypnotics anxiolytics antimuscarinics beta blockers etc Subjects who have been on a stable dose of hypnotic or anxiolytic GABA or Histamine-based for at least 4 weeks prior to study entry may opt to continue these at current dose or be washed out prior to study start Aripiprazole will be dispensed biweekly and the participants will be followed for 6-weeks Participants will be monitored every other week by the HAMD blinded CGI and SAFTEE Vital signs and weight will also be taken at each visit After 6 weeks there will be a two-week taper of aripiprazole 50 reduction in dose per week Compliance will be measured by pill count All subjects will be voluntarily offered to stay in the study for an additional six weeks where they will meet one final time at the end of week 12 to re-evaluate safety and effectiveness of longer term aripiprazole augmentation Subjects would then go through a two week taper as above Subjects who do not wish to continue an additional six weeks may opt out of the study at the original 6 week termination mark If interim safety analysis by independent psychiatrist TBD suggests good safety profile and amendment will be sent to the IRB asking for 10 additional subjects to be enrolled
Primary and secondary measures and safety evaluations The primary measures of the study will be changes in HAMD scores over time we will monitor this to make sure depression scores do not worsen with aripiprazole the secondary efficacy measure will be changes in CGI scores over time Safety evaluations will be determined by the SAFTEE rating scale and patient AE reports An Expectancy Scale will be given to determine if subjects level of perceived confidence in the drug correlates to the outcomes noted above This is a superficial way to look at placebo-like rates when placebo is not used in the study
After screening and consenting and liaison with a primary prescriber 10 eligible subjects will receive aripiprazole 10-30 mg per day as an augmentation agent in combination with their current FDA approved antidepressant medication The dose of the subjects original antidepressant will remain unchanged during the study unless subject notes intolerable newly emergent antidepressant-related side effects Based on tolerability and response aripiprazole will be started at 5 mg per day and augmented as follows baseline end of week 1 end of week 2 end of week 4 and termination visit end of week 6 at 5 mg per day increments the maximum dose being 30 mg per day for patients who are taking antidepressants that have no pre-existing significant inhibitory effect on CYP450 2D6 enzyme system However if the patient is taking any antidepressant that has significant CYP450 2D6 enzyme inhibitory properties that may affect the metabolism of aripiprazole eg paroxetine fluoxetine the maximum dose will be 15 mg per day 50 less than the maximum recommended dose These dose ranges have been chosen because they capture the mean effective dose for ameliorating depressive symptoms in schizophrenia The dose will be titrated upward or downward based on clinical response Other psychotropic medications will be permitted during the study if deemed necessary to control side effects hypnotics anxiolytics antimuscarinics beta blockers etc Subjects who have been on a stable dose of hypnotic or anxiolytic GABA or Histamine-based for at least 4 weeks prior to study entry may opt to continue these at current dose or be washed out prior to study start Aripiprazole will be dispensed biweekly and the participants will be followed for 6-weeks Participants will be monitored every other week by the HAMD blinded CGI and SAFTEE Vital signs and weight will also be taken at each visit After 6 weeks there will be a two-week taper of aripiprazole 50 reduction in dose per week Compliance will be measured by pill count All subjects will be voluntarily offered to stay in the study for an additional six weeks where they will meet one final time at the end of week 12 to re-evaluate safety and effectiveness of longer term aripiprazole augmentation Subjects would then go through a two week taper as above Subjects who do not wish to continue an additional six weeks may opt out of the study at the original 6 week termination mark If interim safety analysis by independent psychiatrist TBD suggests good safety profile and amendment will be sent to the IRB asking for 10 additional subjects to be enrolled
Primary and secondary measures and safety evaluations The primary measures of the study will be changes in HAMD scores over time we will monitor this to make sure depression scores do not worsen with aripiprazole the secondary efficacy measure will be changes in CGI scores over time Safety evaluations will be determined by the SAFTEE rating scale and patient AE reports An Expectancy Scale will be given to determine if subjects level of perceived confidence in the drug correlates to the outcomes noted above This is a superficial way to look at placebo-like rates when placebo is not used in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1040272-1 32678 | None | None | None |