Bipolar DisorderPhase 3NCT01979133

Study of Icariin for Bipolar Disorder and Co-Occurring Substance Use Disorders

A Phase 3 study testing Icariin in people with Bipolar Disorder and Substance Use Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

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

Official record

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Trial summary

This study is being done to see if icariin will help with depression in patients with bipolar disorder and alcohol or cocaine use disorders. The pills used in this study contain 20% icariin. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Bipolar Disorder, Substance Use Disorder
What is being tested?: Icariin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: Oct 2013to Jun 2015
Phase: Phase 3
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Current BPD I, II or NOS and cocaine or alcohol use disorder with HAMD score of ≥ 15
Cocaine or alcohol use with 5 days of initiating study drug
Men and women
Age 18-70 years

Who cannot join

Psychotic features
Non-English speakers
Treatment resistant depression defined as failure of a trial of antidepressants (≥ 4 weeks at a therapeutic dose) in current episode
Major medical condition including heart, lung, liver or renal disease, cancer, neurological or immunological conditions
Vulnerable populations including prisoners, cognitively impaired individuals, and pregnant or nursing women
Prior side effects or allergic reactions to icariin-containing preparations
Change in psychotropic medications within 14 days of study entry
Current suicidal ideation (plan and intent), a suicide attempt within the past 12 months or history of > 1 lifetime suicide attempt

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8849

Other trials in United States

About this study

Official title: A Proof of Concept Study of Icariin for Bipolar Disorder and Co-Occurring Substance Use Disorders

This study is being done to see if icariin will help with depression in patients with bipolar disorder and alcohol or cocaine use disorders. The pills used in this study contain 20% icariin.

Read the detailed description

Ten adults with current bipolar disorder (BPD) and current cocaine or alcohol use disorders, based on a structured clinical interview (SCID), and a baseline Hamilton Rating Scale for Depression (HAMD) score of ≥ 15, will be recruited through a patient database of a recently completed study of bipolar disorder patients with cocaine dependence. Informed consent will be obtained. The clinician version of the structured Clinical Interview for DSM-IV (SCID) is a brief structured interview for major Axis I disorders in DSM-IV including major depressive disorder, dysthymic disorder, bipolar disorders, psychotic disorders, anxiety disorders, eating disorders, and alcohol and substance abuse/dependence. This will be given at baseline to confirm bipolar disorder diagnosis. Blood draws and a physical examination by a physician will be performed at baseline to general physical health. Participants will return to receive icariin (100 mg/day)once their general health and diagnosis are confirmed.

Participants will be assessed at baseline and weekly with the HAMD and a urine drug screen, for 8 consecutive weeks after initiating intervention (icariin). A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 for participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.

Pill counts will be conducted, and a list of current medications and doses will be obtained at each visit. Participants will be compensated and receive bus passes at each appointment. Participants will be evaluated by both the research assistant (RA) and principal investigator (PI) at each follow-up appointment.

The HAM-D will be the primary outcome measure. Other cognitive assessments will be performed at these same visits as well.

Conditions: Bipolar Disorder, Substance Use Disorder
Being tested: Icariin
Medical subject headings: Bipolar Disorder, Substance-Related Disorders

What participants receive

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

IcariinDrug
Also called Epimedium, Horny Goat Weed, Yin Yang Huo
Participants will receive 20% icariin (100 mg/day) in a commercially available over-the-counter Horny Goat Weed supplement. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.

Study groups in NCT01979133
Study group	Role	What they receive
icariin	Experimental	Icariin will be given 100 mg/day. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 for participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen. Receives: Drug: Icariin

What is being measured

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

Change in Hamilton Rating Scale of Depression (HAMD) From Baseline to Week 8 (Exit)
HAMD is an observer-rated measure of depressive symptomatology:
1. 17 questions (answers for individual questions range between 0-3 and 0-4). Total score range: 0-52. No subscales for this measure.
2. 0 - no depression; 52 - very severe depression (lower score corresponds to a better outcome).
3. Total score is obtained by summing questions 1-17.
Measured: Baseline vs. Week 8 (Exit)
Change in Hamilton Rating Scale of Anxiety From Baseline to Week 8 (Exit)
HAMA is a 14-item observer rated measure of anxiety symptomatology:
1. 14 items in a scale, no subscales. Individual items are score 0 (no anxiety) to 4 (very severe anxiety).
2. Total scores range from 0-56.
3. Total scores represent more severe anxiety. Lower scores represent a better outcome.
Measured: Baseline vs. Week 8 (Exit)
Change in Quick Inventory of Depressive Symptomatology (QIDS) Score From Baseline to Week 8
The QIDS is a 16-item self-report measure of depressive symptomatology:
1. 16 items rated on a scale from 0-3. No subscales for this instrument.
2. Total score range is 0-27, where higher score represents higher levels of depression. Lower scores associated with better outcomes.
3. Total score is obtained using the following formula: highest score on items 1-4 + item 5 + highest score on items 6-9 + item 10+item 11+item12+item13+item14+highest score on items 15-16
Measured: Baseline vs. Week 8 (Exit)
Change in Number of Standard Drinks of Alcohol Per Week Baseline vs. Week 8 (Exit)
1. Participants are asked to identify the number of alcoholic drinks they consumed on each day within the last 7 days from the day of visit (not including the day of visit). Participants are asked to provide alcohol name and the amount of alcohol they consumed. These values are then converted to standard drinks using a standard drinks calculator.
2. The minimum number of drinks per week is 0. There is no maximum number of drinks per week, as the maximum number is unique to each participant.
3. The general convention for standard drinks used in this study is as follows (oz per one standard drink):
- beer: 12 fl oz (5% ABV)
- wine: 5 fl oz (10-12% ABV or 18-20% ABV for fortified wine)
- hard liquor: 1.5 fl oz (40% ABV)
Measured: Baseline vs. Week 8 (Exit)
Change in Number of Heavy Drinking Days From Baseline to Week 8 (Exit)
1. Heavy drinking day is defined as 5 standard drinks per day for men, and 4 standard drinks per day for women.
2. Minimum score is 0 (no drinks); maximum score is unique to each individual participant. Lower score represents a better outcome.
3. Average number of heavy drinking days per week is calculated by asking participants to identify the number of drinks they had on each day during the past 7 days (not including the day of visit).
4. See outcome measure description for "standard drinks per week" for standard drinks convention.
Measured: Baseline vs. Week 8 (Exit)
Change in Days of Alcohol Use From Baseline to Week 8 (Exit)
1. Total score range is 0-7 (no days of alcohol use - 7 days of alcohol use). The lower score represents better outcome.
2. Participants are asked to identify days on which they used alcohol in the past week (not including the day of visit).
Measured: Baseline vs. Week 8 (Exit)
Change in Young Mania Rating Scale (YMRS) From Baseline to Week 8 (Exit)
The YMRS is an 11-item observer-rated measure of mania symptomatology:
1. 7 individual items are scored between 0-4.
2. 4 individual items are scored between 0-8.
3. Total score range is 0-60, with no subscales. Higher score is indicative of more manic symptoms. Lower score represents better outcomes.
4. Total score is obtained by adding items on the scale together.
Measured: Baseline vs. Week 8 (Exit)

Timeline

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

Oct 2013Jun 2015

First posted8 Nov 2013 (estimated)
Study startOct 2013
Primary completionJun 2015
Study completionJun 2015

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 Bipolar DisorderStudies of the same condition, open and under way.
More trials run by University of Texas Southwestern Medical CenterThe 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01979133
Sponsor's protocol ID: 082013-042
Status last verified: Mar 2017
First submitted: 25 Oct 2013
Last updated: 19 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 Bipolar Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Proof of Concept Study of Icariin for Bipolar Disorder and Co-Occurring Substance Use Disorders
ClinicalTrials.gov ID: NCT01979133
Acronym / sponsor ID: 082013-042
Conditions: Bipolar Disorder, Substance Use Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Study start: Oct 2013
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 8 Nov 2013 (estimated)
Results: Posted 19 Apr 2017

Clinical summary

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

This study is being done to see if icariin will help with depression in patients with bipolar disorder and alcohol or cocaine use disorders. The pills used in this study contain 20% icariin.

Detailed description

The HAM-D will be the primary outcome measure. Other cognitive assessments will be performed at these same visits as well.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
icariin	Experimental	Drug: IcariinIcariin will be given 100 mg/day. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 for participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Current BPD I, II or NOS and cocaine or alcohol use disorder with HAMD score of ≥ 15
Cocaine or alcohol use with 5 days of initiating study drug
Men and women
Age 18-70 years

Key exclusion criteria (8 listed)

Psychotic features
Non-English speakers
Treatment resistant depression defined as failure of a trial of antidepressants (≥ 4 weeks at a therapeutic dose) in current episode
Major medical condition including heart, lung, liver or renal disease, cancer, neurological or immunological conditions
Vulnerable populations including prisoners, cognitively impaired individuals, and pregnant or nursing women

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
IcariinAlso: Epimedium, Horny Goat Weed, Yin Yang HuoParticipants will receive 20% icariin (100 mg/day) in a commercially available over-the-counter Horny Goat Weed supplement. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.	Drug	icariin

Primary outcome

Change in Hamilton Rating Scale of Depression (HAMD) From Baseline to Week 8 (Exit)
Time frame: Baseline vs. Week 8 (Exit)
HAMD is an observer-rated measure of depressive symptomatology: 1. 17 questions (answers for individual questions range between 0-3 and 0-4). Total score range: 0-52. No subscales for this measure. 2. 0 - no depression; 52 - very severe depression (lower score corresponds to a better outcome). 3. Total score is obtained by summing questions 1-17.
Change in Hamilton Rating Scale of Anxiety From Baseline to Week 8 (Exit)
Time frame: Baseline vs. Week 8 (Exit)
HAMA is a 14-item observer rated measure of anxiety symptomatology: 1. 14 items in a scale, no subscales. Individual items are score 0 (no anxiety) to 4 (very severe anxiety). 2. Total scores range from 0-56. 3. Total scores represent more severe anxiety. Lower scores represent a better outcome.
Change in Quick Inventory of Depressive Symptomatology (QIDS) Score From Baseline to Week 8
Time frame: Baseline vs. Week 8 (Exit)
The QIDS is a 16-item self-report measure of depressive symptomatology: 1. 16 items rated on a scale from 0-3. No subscales for this instrument. 2. Total score range is 0-27, where higher score represents higher levels of depression. Lower scores associated with better outcomes. 3. Total score is obtained using the following formula: highest score on items 1-4 + item 5 + highest score on items 6-9 + item 10+item 11+item12+item13+item14+highest score on items 15-16
Change in Number of Standard Drinks of Alcohol Per Week Baseline vs. Week 8 (Exit)
Time frame: Baseline vs. Week 8 (Exit)
1. Participants are asked to identify the number of alcoholic drinks they consumed on each day within the last 7 days from the day of visit (not including the day of visit). Participants are asked to provide alcohol name and the amount of alcohol they consumed. These values are then converted to standard drinks using a standard drinks calculator. 2. The minimum number of drinks per week is 0. There is no maximum number of drinks per week, as the maximum number is unique to each participant. 3. The general convention for standard drinks used in this study is as follows (oz per one standard drink): * beer: 12 fl oz (5% ABV) * wine: 5 fl oz (10-12% ABV or 18-20% ABV for fortified wine) * hard liquor: 1.5 fl oz (40% ABV)
Change in Number of Heavy Drinking Days From Baseline to Week 8 (Exit)
Time frame: Baseline vs. Week 8 (Exit)
1. Heavy drinking day is defined as 5 standard drinks per day for men, and 4 standard drinks per day for women. 2. Minimum score is 0 (no drinks); maximum score is unique to each individual participant. Lower score represents a better outcome. 3. Average number of heavy drinking days per week is calculated by asking participants to identify the number of drinks they had on each day during the past 7 days (not including the day of visit). 4. See outcome measure description for "standard drinks per week" for standard drinks convention.
Change in Days of Alcohol Use From Baseline to Week 8 (Exit)
Time frame: Baseline vs. Week 8 (Exit)
1. Total score range is 0-7 (no days of alcohol use - 7 days of alcohol use). The lower score represents better outcome. 2. Participants are asked to identify days on which they used alcohol in the past week (not including the day of visit).
Change in Young Mania Rating Scale (YMRS) From Baseline to Week 8 (Exit)
Time frame: Baseline vs. Week 8 (Exit)
The YMRS is an 11-item observer-rated measure of mania symptomatology: 1. 7 individual items are scored between 0-4. 2. 4 individual items are scored between 0-8. 3. Total score range is 0-60, with no subscales. Higher score is indicative of more manic symptoms. Lower score represents better outcomes. 4. Total score is obtained by adding items on the scale together.

Results and safety

Results posted to the registry on 19 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Icariin	10	7

Primary outcome: Change in Hamilton Rating Scale of Depression (HAMD) From Baseline to Week 8 (Exit)

Time frame: Baseline vs. Week 8 (Exit). Mean (Standard Deviation). Unit: HAMD scale units

Measure	Baseline n = 9	Week 8 n = 9
Value	17.5 (5.2)	9 (7.4)

Baseline vs Week 8: p = .012, Wilcoxon (Mann-Whitney)

Population analysed: The total enrollment goal was 10. One participant dropped out during the baseline II visit, thus week 8 score was not obtained for that participant and the change from baseline to week 8 could not be collected. Thus, the analysis includes 9 participants instead of proposed 10.

Primary outcome: Change in Hamilton Rating Scale of Anxiety From Baseline to Week 8 (Exit)

Time frame: Baseline vs. Week 8 (Exit). Mean (Standard Deviation). Unit: HAMA units on a scale

Measure	Baseline n = 9	Week 8 n = 9
Value	15.2 (6.4)	4.6 (6.3)

Baseline vs Week 8: p = .005, Wilcoxon (Mann-Whitney)

Population analysed: The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a results, the overall number of participants analyzed was 9.

Primary outcome: Change in Quick Inventory of Depressive Symptomatology (QIDS) Score From Baseline to Week 8

Time frame: Baseline vs. Week 8 (Exit). Mean (Standard Deviation). Unit: QIDS units on a scale

Measure	Baseline n = 9	Week 8 n = 9
Value	11.8 (5.9)	5.7 (4.5)

Baseline vs Week 8: p = .017, Wilcoxon (Mann-Whitney)

Population analysed: The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.

Primary outcome: Change in Number of Standard Drinks of Alcohol Per Week Baseline vs. Week 8 (Exit)

Time frame: Baseline vs. Week 8 (Exit). Mean (Standard Deviation). Unit: Drinks per week

Measure	Baseline n = 9	Week 8 n = 9
Value	38.8 (45.9)	10.3 (8.2)

Baseline vs Week 8: p = .038, Wilcoxon (Mann-Whitney)

Population analysed: The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Icariin	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
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.

Edson S Brown, M.D., Ph.D. principal investigator

University of Texas Southwestern Medical Center

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Icariin in people with Bipolar Disorder and Substance Use Disorder, run by University of Texas Southwestern Medical Center 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 4 inclusion and 8 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 19 Apr 2017. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 19 Apr 2017). 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?

Change in Hamilton Rating Scale of Depression (HAMD) From Baseline to Week 8 (Exit) (time frame: Baseline vs. Week 8 (Exit)). The study lists 7 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 NCT01979133.

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 19 Apr 2017.