Intranasal Insulin Treatment in Patients With Schizophrenia

A Phase 4 study of Schizophrenia, run by University of Massachusetts, Worcester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is an 8-week, randomized, double-blind, placebo-controlled trial of intranasal insulin as an adjunctive therapy, with a 4-week follow-up, in 60 non-diabetic schizophrenia subjects to examine insulin's effect on psychopathology and cognition. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: 1 siteUnited States
Study dates: Dec 2007to Sep 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-65 years.
Diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype.
Stable dose of the current antipsychotic drug for at least one month.
Well established compliance with outpatient treatment per treating clinician's judgement.
Able to complete the cognitive assessment battery (must be English speaking).
Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods (complete abstinence from sexual intercourse, female sterilization, sterilization of male partner, implants of levonorgestrel, injectable progestogen, oral contraceptives, intrauterine devices, or double barrier methods of contraception using spermicide with either a condom or diaphragm) during the study.

Who cannot join

Inability to provide informed consent.
Current substance abuse.
Psychiatrically unstable per treating clinician's judgement.
Significant medical illnesses including uncontrolled hypertension, diabetes, seizure. disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases.
Pregnancy or breastfeeding.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Massachusetts Medical School
Worcester, Massachusetts, 01605

Other trials in United States

About this study

Read the detailed description

The specific aims include:

Primary aims

Examine the efficacy of intranasal regular insulin (40 IU 4 times per day) in improving cognitive deficits in patients with schizophrenia.
Examine the efficacy of intranasal regular insulin in improving negative symptoms and positive symptoms of schizophrenia.

Secondary aims

Examine intranasal insulin's effects on weight, food intake and resting energy expenditure.
Examine intranasal insulin's effects on body composition, waist circumference, and waist/hip ratio.

Conditions: Schizophrenia
Being tested: Insulin or Placebo
Keywords: cognition, psychopathology
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Insulin or PlaceboDrug
intranasal, 40IU, 4 times daily

Study groups in NCT00575666
Study group	Role	What they receive
A	Experimental	Intranasal Insulin Treatment Receives: Drug: Insulin or Placebo
B	Placebo comparator	Drug: Placebo Receives: Drug: Insulin or Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Cognitive Function- Digit Span Total
Subjects completed the digit span task. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 30. Week 8 values are displayed below.
Measured: Week 8
Cognitive Function- Verbal Fluency
Subjects completed a verbal fluency test. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher levels of verbal fluency, and therefore less advanced psychopathology. Min score= 0, Max score= N/A. Week 8 values are displayed below.
Measured: Week 8
Cognitive Function- HVLT Immediate Recall Total
Subjects completed a word recall task. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 36. Week 8 values are displayed below.
Measured: Week 8
Cognitive Function- HVLT Delayed Recall Total
Subjects completed a delayed word recall task. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 12. Week 8 values are displayed below.
Measured: Week 8
Cognitive Function- Trails A
Subjects completed a timed "trails" (i.e. connect-the-dots) test. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were measured by time to complete in seconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below.
Measured: Week 8
Cognitive Function- Trails B
Subjects completed a timed "trails" (i.e. connect the dots) test. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were mesured by time to complete in seconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below.
Measured: Week 8
Cognitive Function- CPT D Prime Score
Subjects completed a computer-based cognitive test designed to measure sustained attention (attention to a specific stimulus over a period of several minutes) before and after intranasal treatment. During this test, participants respond as quickly as possible to any consecutive presentation of identical stimuli on the computer screen. The stimuli (2, 3, and 4-digit targets) were presented with increasing cognitive load in successive blocks. Correct responses, responses made to the second of 2 identical stimuli presented in a row, were scored as hits. False alarms were also recorded. The "d prime score" is a score given to each participant on a scale of 0.0- 1.0 in which discrimination sensitivity is measured. A score of zero equates to no sensitivity, whereas a score of 1.0 equates to perfect sensitivity. Values below represent postreatment performance minus pretreatment performance. Higher scores represent less advanced psychopathology. Week 8 values are displayed below.
Measured: Week 8
Cognitive Function- CPT Hits Rate (Proportion)
Subjects completed a computer-based cognitive test. The test is described in detail in a previous outcome measure ("CPT d prime score"). Hits rate was defined as the proportion of correct responses to the relevant stimuli (response to two identical targets) compared to total responses (total hits). Assessments were completed at Screening/Baseline, Week 4, and Week 8. Hits rate as a proportion of total hits was measured. Min score= 0, Max score= 1.0. Higher values represent higher stimulus recognition accuracy, and thus less advanced psychopathology. Week 8 values are displayed below.
Measured: Week 8
Cognitive Function- CPT Reaction Time of Hits (Milliseconds)
Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes). The test is described in detail in a previous outcome measure ("CPT d prime score"). Reaction time of hits is defined as the average time each participant took to respond correctly to relevant stimuli. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Reaction time was measured in milliseconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below.
Measured: Week 8
Cognitive Function- CPT False-alarm Rate (Proportion)
Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes). False alarm rate is defined as the proportion of overall hits that were in response to an incorrect stimulus (two consecutive non-identical targets). Assessments were completed at Screening/Baseline, Week 4, and Week 8. False-alarm hits were measured as a proportion of total hits. Min score= 0, Max score= 1.0. Lower values represent higher hit accuracy and less advanced psychopathology. Week 8 values are displayed below.
Measured: Week 8
Psychopathology- PANSS Total
Positive symptoms, negative symptoms, and general psychopatholgy of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of 30 total items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 30, Max score= 210. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.
Measured: Week 8
Psychopathology- PANSS Positive
Positive symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of seven items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 7, Max score= 49. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.
Measured: Week 8
Psychopathology- PANSS Negative
Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of seven-items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 7, Max score= 49. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.
Measured: Week 8
Psychopathology- PANSS General Psychopathology
General psychopathology was measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of 16 items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 16, Max score= 112. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.
Measured: Week 8
Psychopathology- SANS Total
Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 25 items, with each item measured on a six-point scale (0= none, 3= moderate, 5= severe). Min score= 0, Max score= 125. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.
Measured: Week 8
Psychopathology- CDSS Total
Symptoms of depression were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 9 items, with each item measured on a four-point scale (0= absent, 3= severe). Min score= 0, Max score= 27. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.
Measured: Week 8
Psychopathology- QLS Total
Quality of life was measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 21 items, with each item measured on a seven-point scale (0= not present, 3= sometimes present, 6= always present). Min score= 0, Max score= 126. Higher scores represent lower quality of life. Week 8 values are displayed below.
Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007Sep 2010

First posted18 Dec 2007 (estimated)
Study startDec 2007
Primary completionSep 2010
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00575666
Sponsor's protocol ID: 2007-P-000731
Status last verified: Nov 2012
First submitted: 14 Dec 2007
Last updated: 17 Dec 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intranasal Insulin Treatment in Patients With Schizophrenia
ClinicalTrials.gov ID: NCT00575666
Acronym / sponsor ID: 2007-P-000731
Conditions: Schizophrenia
Keywords: cognition, psychopathology
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: University of Massachusetts, WorcesterUniversity, hospital or other
Collaborators: National Alliance for Research on Schizophrenia and Depression, Eli Lilly and Company
Study start: Dec 2007
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 18 Dec 2007 (estimated)
Results: Posted 17 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The specific aims include:

Primary aims

Examine the efficacy of intranasal regular insulin (40 IU 4 times per day) in improving cognitive deficits in patients with schizophrenia.
Examine the efficacy of intranasal regular insulin in improving negative symptoms and positive symptoms of schizophrenia.

Secondary aims

Examine intranasal insulin's effects on weight, food intake and resting energy expenditure.
Examine intranasal insulin's effects on body composition, waist circumference, and waist/hip ratio.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: Insulin or PlaceboIntranasal Insulin Treatment
B	Placebo comparator	Drug: Insulin or PlaceboDrug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age 18-65 years.
Diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype.
Stable dose of the current antipsychotic drug for at least one month.
Well established compliance with outpatient treatment per treating clinician's judgement.
Able to complete the cognitive assessment battery (must be English speaking).

Key exclusion criteria (5 listed)

Inability to provide informed consent.
Current substance abuse.
Psychiatrically unstable per treating clinician's judgement.
Significant medical illnesses including uncontrolled hypertension, diabetes, seizure. disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases.
Pregnancy or breastfeeding.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Insulin or Placebointranasal, 40IU, 4 times daily	Drug	A, B

Primary outcome

Cognitive Function- Digit Span Total
Time frame: Week 8
Subjects completed the digit span task. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 30. Week 8 values are displayed below.
Cognitive Function- Verbal Fluency
Time frame: Week 8
Subjects completed a verbal fluency test. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher levels of verbal fluency, and therefore less advanced psychopathology. Min score= 0, Max score= N/A. Week 8 values are displayed below.
Cognitive Function- HVLT Immediate Recall Total
Time frame: Week 8
Subjects completed a word recall task. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 36. Week 8 values are displayed below.
Cognitive Function- HVLT Delayed Recall Total
Time frame: Week 8
Subjects completed a delayed word recall task. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 12. Week 8 values are displayed below.
Cognitive Function- Trails A
Time frame: Week 8
Subjects completed a timed "trails" (i.e. connect-the-dots) test. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were measured by time to complete in seconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below.
Cognitive Function- Trails B
Time frame: Week 8
Subjects completed a timed "trails" (i.e. connect the dots) test. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were mesured by time to complete in seconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below.
Cognitive Function- CPT D Prime Score
Time frame: Week 8
Subjects completed a computer-based cognitive test designed to measure sustained attention (attention to a specific stimulus over a period of several minutes) before and after intranasal treatment. During this test, participants respond as quickly as possible to any consecutive presentation of identical stimuli on the computer screen. The stimuli (2, 3, and 4-digit targets) were presented with increasing cognitive load in successive blocks. Correct responses, responses made to the second of 2 identical stimuli presented in a row, were scored as hits. False alarms were also recorded. The "d prime score" is a score given to each participant on a scale of 0.0- 1.0 in which discrimination sensitivity is measured. A score of zero equates to no sensitivity, whereas a score of 1.0 equates to perfect sensitivity. Values below represent postreatment performance minus pretreatment performance. Higher scores represent less advanced psychopathology. Week 8 values are displayed below.
Cognitive Function- CPT Hits Rate (Proportion)
Time frame: Week 8
Subjects completed a computer-based cognitive test. The test is described in detail in a previous outcome measure ("CPT d prime score"). Hits rate was defined as the proportion of correct responses to the relevant stimuli (response to two identical targets) compared to total responses (total hits). Assessments were completed at Screening/Baseline, Week 4, and Week 8. Hits rate as a proportion of total hits was measured. Min score= 0, Max score= 1.0. Higher values represent higher stimulus recognition accuracy, and thus less advanced psychopathology. Week 8 values are displayed below.
Cognitive Function- CPT Reaction Time of Hits (Milliseconds)
Time frame: Week 8
Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes). The test is described in detail in a previous outcome measure ("CPT d prime score"). Reaction time of hits is defined as the average time each participant took to respond correctly to relevant stimuli. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Reaction time was measured in milliseconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below.
Cognitive Function- CPT False-alarm Rate (Proportion)
Time frame: Week 8
Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes). False alarm rate is defined as the proportion of overall hits that were in response to an incorrect stimulus (two consecutive non-identical targets). Assessments were completed at Screening/Baseline, Week 4, and Week 8. False-alarm hits were measured as a proportion of total hits. Min score= 0, Max score= 1.0. Lower values represent higher hit accuracy and less advanced psychopathology. Week 8 values are displayed below.
Psychopathology- PANSS Total
Time frame: Week 8
Positive symptoms, negative symptoms, and general psychopatholgy of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of 30 total items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 30, Max score= 210. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.
Psychopathology- PANSS Positive
Time frame: Week 8
Positive symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of seven items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 7, Max score= 49. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.
Psychopathology- PANSS Negative
Time frame: Week 8
Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of seven-items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 7, Max score= 49. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.
Psychopathology- PANSS General Psychopathology
Time frame: Week 8
General psychopathology was measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of 16 items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 16, Max score= 112. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.
Psychopathology- SANS Total
Time frame: Week 8
Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 25 items, with each item measured on a six-point scale (0= none, 3= moderate, 5= severe). Min score= 0, Max score= 125. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.
Psychopathology- CDSS Total
Time frame: Week 8
Symptoms of depression were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 9 items, with each item measured on a four-point scale (0= absent, 3= severe). Min score= 0, Max score= 27. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.
Psychopathology- QLS Total
Time frame: Week 8
Quality of life was measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 21 items, with each item measured on a seven-point scale (0= not present, 3= sometimes present, 6= always present). Min score= 0, Max score= 126. Higher scores represent lower quality of life. Week 8 values are displayed below.

Results and safety

Results posted to the registry on 17 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention: Insulin	21	17
Intervention: Placebo	24	21

Primary outcome: Cognitive Function- Digit Span Total

Time frame: Week 8. Mean (Standard Deviation). Unit: Items correct

Measure	Humulin n = 17	Placebo n = 21
Value	13.3 (4.0)	14.1 (4.9)

Population analysed: All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.

Primary outcome: Cognitive Function- Verbal Fluency

Time frame: Week 8. Mean (Standard Deviation). Unit: Words correct

Measure	Humulin n = 17	Placebo n = 21
Value	27.9 (11.6)	28.0 (13.3)

Population analysed: All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.

Primary outcome: Cognitive Function- HVLT Immediate Recall Total

Time frame: Week 8. Mean (Standard Deviation). Unit: Words correct

Measure	Humulin n = 17	Placebo n = 21
Value	21.4 (8.4)	23.6 (7.1)

Population analysed: All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.

Primary outcome: Cognitive Function- HVLT Delayed Recall Total

Time frame: Week 8. Mean (Standard Deviation). Unit: Words correct

Measure	Humulin n = 17	Placebo n = 21
Value	6.8 (3.6)	7.8 (3.2)

Population analysed: All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.

Adverse events

Time frame: Data was monitored for potential SAEs and AEs for a period of 34 months. For each individual subject, the timeframe for SAE and AE reporting was 12 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention: Insulin	0 of 21 (0%)	0 of 21 (0%)	Not reported
Intervention: Placebo	0 of 24 (0%)	0 of 24 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xiaoduo Fan, MD, MPH, MS principal investigator

UMass Medical School

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study of Schizophrenia, run by University of Massachusetts, Worcester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive Function- Digit Span Total (time frame: Week 8). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00575666.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2012.