Bipolar DisorderPhase 4NCT02082678

Ondansetron for Bipolar Disorder and Alcohol Use Disorders

A Phase 4 study testing Ondansetron in people with Bipolar Disorder and Alcohol 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

The purpose of the study is to determine if ondansetron, as an add-on therapy, is associated with reduced depressive symptoms and alcohol use in outpatients with bipolar disorder (BPD), cyclothymic disorder, schizoaffective disorder (bipolar type) and major depressive disorder (MDD) with mixed features. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Bipolar Disorder, Alcohol Use Disorder, Dual Diagnosis
What is being tested?: Ondansetron
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 1 siteUnited States
Study dates: Feb 2014to May 2018
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Outpatient men and women age 18-70 years old with bipolar I, II, or Not Otherwise Specified (NOS) disorders, schizoaffective disorder (bipolar type), cyclothymic disorder, or major depressive disorder with mixed features
Current diagnosis of alcohol use disorder (DSM V terminology) with onset ≤ age 25
Alcohol use (by self-report) of at least 15 drinks in the 7 days prior to intake
IF diagnosis of Bipolar I, II, or NOS Disorder: Current mood stabilizer therapy (lithium, anticonvulsant, atypical antipsychotic) with stable dose for at least 14 days prior to randomization
IF diagnosis of Schizoaffective disorder (bipolar type): Current atypical antipsychotic therapy with stable dose for at least 14 days prior to randomization
IF diagnosis of Major Depressive Disorder with mixed features: Current antidepressant therapy with stable dose for at least 14 days prior to randomization

Who cannot join

Baseline Young Mania Rating Scale (YMRS) or Hamilton Rating Scale for Depression (HAMD) scores ≥ 35 to exclude those with very severe mood symptoms
Evidence of clinically significant alcohol withdrawal symptoms defined as a CIWA-Ar (Clinical Institute Withdrawal Assessment of Alcohol Use-Revised) score of ≥ 10
Therapy in past 14 days with naltrexone, acamprosate, disulfiram, or topiramate
Vulnerable populations (e.g. pregnant, breastfeeding, incarcerated, cognitively impaired (e.g. dementia, mentally challenged))
High risk of suicide defined as > 1 attempt in past 12 months that required medical attention, any attempt in the past 3 months or current suicidal ideation with plan and intent such that outpatient care is precluded
Intensive outpatient treatment (defined as ≥ 3 visits each week) for substance abuse (AA, NA meetings, or less intensive counseling at baseline will be allowed)

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Severe or life-threatening medical condition (e.g., hepatic cirrhosis) or laboratory or physical examination findings consistent with serious medical illness (e.g., dangerously abnormal electrolytes)
AST (aspartate aminotransferase ) or ALT (alanine transaminase) > 3 times the upper limit of normal
History of severe side effects or allergic reaction with prior ondansetron therapy (e.g. for vomiting) or use of medications with significant drug-drug interactions with ondansetron (phenytoin, carbamazepine, and rifampicin, apomorphine, tramadol)

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

Read the detailed description

A total of 70 outpatients with alcohol use disorder and BPD, cyclothymic disorder, schizoaffective disorder (bipolar type), or MDD with mixed features will be enrolled in a 12-week, randomized, double-blind, parallel-group, placebo-controlled study of ondansetron. Participant will receive either ondansetron or a placebo for 12 weeks. He or she has an equal chance of receiving ondansetron or placebo.

Randomization will be stratified based on > 4 or ≤ 4 drinking days per week at start of the study. Ondansetron or placebo will be given at 0.5 milligrams twice a day for the first 4 weeks. At weeks 4, 8 and 10 the dose may be increased to 1.0, 2.0 or 4.0 milligrams twice a day, respectively, if significant reductions in depression and alcohol use are not observed and the participant is not experiencing any side effects. Blood will be drawn for routine laboratory analyses including a complete blood count (CBC), liver panel, and Carbohydrate-deficient Transferrin (CDT) at baseline and weeks 4, 8 and 12.

Each participant will return for weekly follow-up visits and repeat outcome measures. Pill counts will be conducted, and a list of current medications and doses will be recorded at each visit. Participants will be compensated at each appointment with a bus pass, gift cards, and a monetary incentive for compliance. Participants will be evaluated by both the research assistant (RA) and principal investigator (PI) at each visit.

The Hamilton Rating Scale for Depression (HAMD) and Timeline Followback (TLFB) will be given at each visit as the primary outcome measures. Cognitive assessments will be performed at baseline and week 12.

Conditions: Bipolar Disorder, Alcohol Use Disorder, Dual Diagnosis
Being tested: Ondansetron, Placebo
Keywords: Bipolar Disorder, BPD, Alcohol Use Disorder, Alcohol Abuse, Alcohol Dependence, Ondansetron, Cognition, Mood
Medical subject headings: Bipolar Disorder, Alcoholism

What participants receive

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

OndansetronDrug
Also called Zofran, Zuplenz
Ondansetron is a serotonin receptor antagonist that is FDA-approved to treat nausea and vomiting caused by cancer therapy and surgery.
PlaceboDrug
Also called Sugar-pill
Inactive ingredient matching the active medication in appearance

Study groups in NCT02082678
Study group	Role	What they receive
Ondansetron	Active comparator	Ondansetron will be given 0.5 mg twice a day (BID). The dose may be increased from 0.5 mg/BID to 1.0 mg/BID at week 4 for participants with less than 30% reduction in HAMD and/or alcohol use. An additional dose increase to 2.0 mg/BID and 4.0 mg/BID is allowed at weeks 8 and 10, respectively, for participants with less than a 50% reduction in HAMD scores and/or alcohol use. Receives: Drug: Ondansetron
Placebo	Placebo comparator	Placebo will be given 0.5 mg/ BID. The dose may be increased from 0.5 mg/BID to 1.0 mg/BID at week 4 for participants with less than 30% reduction in HAMD and/or alcohol use. An additional dose increase to 2.0 mg/BID and 4.0 mg/BID is allowed at weeks 8 and 10, respectively, for participants with less than a 50% reduction in HAMD scores and/or alcohol use. Receives: Drug: Placebo

What is being measured

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

Hamilton Rating Scale for Depression (HAMD)
The Hamilton Rating Scale for Depression (HAMD) is a 17-item observer-rated measure of depressive symptomatology. HAMD is scored between 0 and 4 points, with the total score ranging from 0 to 52. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression. The higher scores are associated with greater depressive symptom severity and poorer outcome.
Measured: Baseline and Week 12
Number of Standard Drinks Per Assessment Period on Timeline Followback (TLFB)
The Timeline Followback (TLFB) will be used to assess the change in the number of standard alcoholic drinks per week. The TLFB is interviewer-administered and asks participants to retrospectively estimate their alcohol use between each visit. The reported drinks are then converted to standard drinks based on the drink's alcohol by volume (ABV). The higher number is associated with more standard drinks and worse outcome. Values are corrected for the number of days covered in the assessment period.
Measured: Baseline and Week 12
Number of Heavy Drinking Days Per Assessment Period on Timeline Followback (TLFB)
The Timeline Followback (TLFB) will be used to assess the change in the number of standard alcoholic drinks per week. The TLFB involves asking participants to retrospectively estimate their alcohol between each research visit. The reported drinks are then converted to heavy drinking days based on the drink's alcohol by volume (ABV) and participant's sex (male/female) - 5 drinks per day for males and 4 for females. Each day during which 4-5 drinks are consumed is counted as a heavy drinking day within a given assessment period. The reported values are corrected for days covered (divided by the number of days between each visit). The higher number is associated with more heavy drinking days and worse outcome.
Measured: Baseline and Week 12

Timeline

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

Feb 2014May 2018

First posted10 Mar 2014 (estimated)
Study startFeb 2014
Primary completionMay 2018
Study completionMay 2018

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02082678
Sponsor's protocol ID: 112013-075
Status last verified: Aug 2021
First submitted: 6 Mar 2014
Last updated: 24 Aug 2021
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 Bipolar Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ondansetron for Bipolar Disorder and Alcohol Use Disorders
ClinicalTrials.gov ID: NCT02082678
Acronym / sponsor ID: 112013-075
Conditions: Bipolar Disorder, Alcohol Use Disorder, Dual Diagnosis
Keywords: Bipolar Disorder, BPD, Alcohol Use Disorder, Alcohol Abuse, Alcohol Dependence, Ondansetron, Cognition, Mood
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Collaborators: Stanley Medical Research Institute
Study start: Feb 2014 (actual)
Primary completion: May 2018 (actual)
Study completion: May 2018 (actual)
First posted: 10 Mar 2014 (estimated)
Results: Posted 20 Jul 2020

Clinical summary

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

Detailed description

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
Ondansetron	Active comparator	Drug: OndansetronOndansetron will be given 0.5 mg twice a day (BID). The dose may be increased from 0.5 mg/BID to 1.0 mg/BID at week 4 for participants with less than 30% reduction in HAMD and/or alcohol use. An additional dose increase to 2.0 mg/BID and 4.0 mg/BID is allowed at weeks 8 and 10, respectively, for participants with less than a 50% reduction in HAMD scores and/or alcohol use.
Placebo	Placebo comparator	Drug: PlaceboPlacebo will be given 0.5 mg/ BID. The dose may be increased from 0.5 mg/BID to 1.0 mg/BID at week 4 for participants with less than 30% reduction in HAMD and/or alcohol use. An additional dose increase to 2.0 mg/BID and 4.0 mg/BID is allowed at weeks 8 and 10, respectively, for participants with less than a 50% reduction in HAMD scores and/or alcohol use.

Who may qualify

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

Key inclusion criteria (6 listed)

Outpatient men and women age 18-70 years old with bipolar I, II, or Not Otherwise Specified (NOS) disorders, schizoaffective disorder (bipolar type), cyclothymic disorder, or major depressive disorder with mixed features
Current diagnosis of alcohol use disorder (DSM V terminology) with onset ≤ age 25
Alcohol use (by self-report) of at least 15 drinks in the 7 days prior to intake
IF diagnosis of Bipolar I, II, or NOS Disorder: Current mood stabilizer therapy (lithium, anticonvulsant, atypical antipsychotic) with stable dose for at least 14 days prior to randomization
IF diagnosis of Schizoaffective disorder (bipolar type): Current atypical antipsychotic therapy with stable dose for at least 14 days prior to randomization

Key exclusion criteria (9 listed)

Baseline Young Mania Rating Scale (YMRS) or Hamilton Rating Scale for Depression (HAMD) scores ≥ 35 to exclude those with very severe mood symptoms
Evidence of clinically significant alcohol withdrawal symptoms defined as a CIWA-Ar (Clinical Institute Withdrawal Assessment of Alcohol Use-Revised) score of ≥ 10
Therapy in past 14 days with naltrexone, acamprosate, disulfiram, or topiramate
Vulnerable populations (e.g. pregnant, breastfeeding, incarcerated, cognitively impaired (e.g. dementia, mentally challenged))
High risk of suicide defined as > 1 attempt in past 12 months that required medical attention, any attempt in the past 3 months or current suicidal ideation with plan and intent such that outpatient care is precluded

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
OndansetronAlso: Zofran, ZuplenzOndansetron is a serotonin receptor antagonist that is FDA-approved to treat nausea and vomiting caused by cancer therapy and surgery.	Drug	Ondansetron
PlaceboAlso: Sugar-pillInactive ingredient matching the active medication in appearance	Drug	Placebo

Primary outcome

Hamilton Rating Scale for Depression (HAMD)
Time frame: Baseline and Week 12
The Hamilton Rating Scale for Depression (HAMD) is a 17-item observer-rated measure of depressive symptomatology. HAMD is scored between 0 and 4 points, with the total score ranging from 0 to 52. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression. The higher scores are associated with greater depressive symptom severity and poorer outcome.
Number of Standard Drinks Per Assessment Period on Timeline Followback (TLFB)
Time frame: Baseline and Week 12
The Timeline Followback (TLFB) will be used to assess the change in the number of standard alcoholic drinks per week. The TLFB is interviewer-administered and asks participants to retrospectively estimate their alcohol use between each visit. The reported drinks are then converted to standard drinks based on the drink's alcohol by volume (ABV). The higher number is associated with more standard drinks and worse outcome. Values are corrected for the number of days covered in the assessment period.
Number of Heavy Drinking Days Per Assessment Period on Timeline Followback (TLFB)
Time frame: Baseline and Week 12
The Timeline Followback (TLFB) will be used to assess the change in the number of standard alcoholic drinks per week. The TLFB involves asking participants to retrospectively estimate their alcohol between each research visit. The reported drinks are then converted to heavy drinking days based on the drink's alcohol by volume (ABV) and participant's sex (male/female) - 5 drinks per day for males and 4 for females. Each day during which 4-5 drinks are consumed is counted as a heavy drinking day within a given assessment period. The reported values are corrected for days covered (divided by the number of days between each visit). The higher number is associated with more heavy drinking days and worse outcome.

Results and safety

Results posted to the registry on 20 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ondansetron	35	23
Placebo	35	21

Primary outcome: Hamilton Rating Scale for Depression (HAMD)

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: score on a scale

Measure	Ondansetron n = 35	Placebo n = 35
Baseline	13.77 (5.39)	14.23 (7.25)
Week 12	8.52 (6.02)	8.86 (5.77)

Population analysed: 11 participants from Ondansetron group and 13 from the Placebo group did not complete this study.

Primary outcome: Number of Standard Drinks Per Assessment Period on Timeline Followback (TLFB)

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: mean number of standard drinks per week

Measure	Ondansetron n = 35	Placebo n = 35
Baseline	4.06 (4.07)	4.92 (4.09)
Week 12	2.50 (3.73)	2.92 (2.68)

Primary outcome: Number of Heavy Drinking Days Per Assessment Period on Timeline Followback (TLFB)

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: heavy drinking days (corrected)

Measure	Ondansetron n = 35	Placebo n = 35
Baseline	0.34 (0.33)	0.45 (0.37)
Week 12	0.17 (0.28)	0.20 (0.28)

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ondansetron	10 of 35 (28.6%)	7 of 35 (20%)	1 of 35
Placebo	4 of 35 (11.4%)	4 of 35 (11.4%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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.

E. Sherwood Brown, MD, PhD 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 4 study testing Ondansetron in people with Bipolar Disorder and Alcohol 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 6 inclusion and 9 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 24 Aug 2021. 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 20 Jul 2020). 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?

Hamilton Rating Scale for Depression (HAMD) (time frame: Baseline and Week 12). The study lists 3 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 NCT02082678.

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 24 Aug 2021.