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AzTrials

SchizophreniaPhase 2NCT00709202

Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain

A Phase 2 study testing Betahistine in people with Schizophrenia and Schizoaffective Disorder, run by Nathan Kline Institute for Psychiatric Research 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 study attempts to evaluate a histamine analog long used for the treatment of Meniere's disease, betahistine, that shows promise in reversing the antihistaminergic effects thought to be involved in antipsychotic induced weight gain. Hypothesis to be tested: A. Read more about this study

Who is it for?
Ages 18 to 59 years
What is being tested?
Betahistine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteUnited States
Study dates
Jul 2008to Dec 2016
Phase
Phase 2
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 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adolescents and Adults ages 12-59 with a diagnosis of Schizophrenia, Schizoaffective Disorder, Schizophreniform, Bipolar I, Bipolar II, Bipolar NOS or Psychotic Disorder NOS, Autism Spectrum Disorder
  • Patients will be currently treated with antipsychotics
  • Patients will qualify for entry if they meet the following weight criteria:
  • The patient has gained 7% of their weight since beginning of treatment with one or more of the current antipsychotics.
  • The patient has had an increase of 7% of their weight during the last year while being treated with antipsychotics.
  • The patient has a BMI of 30 or more and has gained 10 lbs or more in the past 8 months while being treated with antipsychotic medications.
  • The patient has a BMI of 35 or greater at the current time, and his chart shows a history of consistent weight gain over the past 1 to 3 years during treatment with antipsychotics.
  • .

Who cannot join

  • Subjects will be excluded if they have asthma, peptic ulcer disease (diseases which may be exacerbated by a histamine analog), or history of pheochromocytoma or peptic ulcer disease. Patients will be excluded if they are prescribed medications known to affect body weight or glucose-lipid metabolism, such as prescription or over the counter medications taken for the purpose of weight reduction. Subjects who are currently treated with metformin, for less than 6 months and have shown recent weight change on metformin. Patients on thyroid replacement therapy or lipid-lowering agents whose dosage has changed by more than 50 % in the past month will be excluded. If they are relatively stable doses of these medications they will not be excluded. Patients who are on lipid lowering medication, thyroid replacement medication, or diabetes medication, (excluding metformin), must remain on these medications throughout the period of the study. Females who are pregnant or breast feeding will be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Nathan Kline Insitute for Psychiatric Research

    Orangeburg, New York, 10962

Other trials in United States

About this study

Official title: The Attenuation of Second Generation Antipsychotic Induced Weight Gain in Adolescents and Adults Using Betahistine: A Double-Blind, Placebo-Controlled Trial

The study attempts to evaluate a histamine analog long used for the treatment of Meniere's disease, betahistine, that shows promise in reversing the antihistaminergic effects thought to be involved in antipsychotic induced weight gain.

Hypothesis to be tested:

  1. Patients who have gained a developmentally inappropriate amount of weight on antipsychotics (AP) will see their weight and BMI decrease with betahistine augmentation as compared to placebo augmentation.
  2. Betahistine augmentation in AP treated patients will increase levels of satiety in a standardized meal situation and decrease caloric intake as compared to placebo augmentation.
  3. Metabolic effects of betahistine augmentation in AP treated patients will be reflected in differences in waist circumference, hip circumference and waist hip ratios D. Betahistine augmentation in this population will lead to decrease in fasting glucose-lipid lab values related to the development of metabolic syndrome as compared to placebo augmentation
Read the detailed description

Subjects for this study were adolescents and adults from age 12 to age 59. Subjects were individuals who have been psychiatrically stabilized on first or second generation antipsychotic medication, and have gained substantial weight during their treatment. Subjects were excluded if they have asthma, peptic ulcer disease (diseases which may be exacerbated by a histamine analog) or are prescribed medications known to affect body composition or metabolism other than those currently being studied. Subjects were randomized to receive either betahistine or placebo at a 1:1 ratio.

Being tested
Betahistine, Placebo Oral Tablet
Medical subject headings
Schizophrenia, Psychotic Disorders, Autism Spectrum Disorder

What participants receive

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

  • BetahistineDrug

    Also called Serc, Betaserc, Betaserk

    Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID (BID = 2 times a day)..

  • Placebo Oral TabletDrug

Study groups in NCT00709202
Study groupRoleWhat they receive
1Active comparatorSubjects assigned to this arm will receive Betahistine.
Receives: Drug: Betahistine
2Placebo comparatorSubjects in this group will received placebo.
Receives: Drug: Placebo Oral Tablet

What is being measured

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

  1. Change in Weight

    Least Squares estimated change in weight from end of study minus baseline

    Measured: Measured at each visit from baseline to end of study over a 12 week period

Secondary outcomes (10)

  1. Change in Body Mass Index (BMI)

    Least Squares estimated change in BMI from end of study minus baseline

    Measured: Measured at each visit from baseline to end of study over a 12 week period.

  2. Change in Waist Circumference

    Least Squares estimated change in waist circumference from end of study minus baseline

    Measured: Measured at each visit from baseline to end of study over a 12 week period.

  3. Change in Hip Circumference

    Least Squares estimated change in hip circumference from end of study minus baseline

    Measured: Measured at each visit from baseline to end of study over a 12 week period.

  4. Change in Glucose

    Least Squares estimated change in glucose from end of study minus baseline

    Measured: Measured at each visit from baseline to end of study over a 12 week period.

  5. Change in Cholesterol

    Least Squares estimated change in cholesterol from end of study minus baseline

    Measured: Measured at each visit from baseline to end of study over a 12 week period.

  6. Change in LDL

    Least Squares estimated change in LDL from end of study minus baseline

    Measured: Measured at each visit from baseline to end of study over a 12 week period.

  7. Change in HDL

    Least Squares estimated change in HDL from end of study minus baseline

    Measured: Measured at each visit from baseline to end of study over a 12 week period.

  8. Change in Triglycerides

    Least Squares estimated change in triglycerides from end of study minus baseline

    Measured: Measured at each visit from baseline to end of study over a 12 week period.

  9. Change in Appetite Hunger

    Least Squares estimated change in appetite hunger from end of study minus baseline.The scale used has no specific name. It is a Visual Analogue Scale, where a line is drawn of 10 cm long with the statement beneath the line" How Hungry do you feel '. The subject places an X on the line. The measurements, the number of centimeters from the start of the line ("O"), indicate the amount of hunger. The higher the cm number the higher the feeling of hunger. The measure reported is the difference in this scale reading in cm from after the test meal to before consuming the test meal. The number (mean, s.e.m) presented is the analysis of covariance model estimated difference score at the end of study, with the covariate of the same score at baseline.

    Measured: Measured at baseline and 12 weeks

  10. Change in Appetite Fullness

    Least Squares estimated change in appetite fullness from end of study minus baseline.The scale used has no specific name. It is a Visual Analogue Scale, where a line is drawn of 10 cm long with the statement beneath the line" How full do you feel '. The subject places an X on the line. The measurements, the number of centimeters from the start of the line ("O"). indicate amount of feeling of fullness. The higher the cm number the higher the feeling of fullness. The measure reported is the difference in this scale reading in cm from after the test meal to before consuming the test meal. The number (mean, s.e.m.) presented is the analysis of covariance model estimated difference score at the end of study, with the covariate of the same score at baseline.

    Measured: .Measured at baseline and 12 weeks

Timeline

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

  1. First posted3 Jul 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionMay 2016
  4. Study completionDec 2016

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00709202
Sponsor's protocol ID
07TGF-1112
Status last verified
Jan 2019
First submitted
1 Jul 2008
Last updated
25 Jan 2019
Data monitoring committee
No
Individual data sharing
No

Publications

  • Kang D, Jing Z, Li R, Hei G, Shao T, Li L, Sun M, Yang Y, Wang Y, Wang X, Long Y, Huang X, Wu R. Effect of Betahistine and Metformin on Antipsychotic-Induced Weight Gain: An Analysis of Two Clinical Trials. Front Psychiatry. 2018 Nov 27;9:620. doi: 10.3389/fpsyt.2018.00620. eCollection 2018.

    PubMed 30542300

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Betahistine in people with Schizophrenia and Schizoaffective Disorder, run by Nathan Kline Institute for Psychiatric Research 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 8 inclusion and 1 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 25 Jan 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 25 Jan 2019). 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 Weight (time frame: Measured at each visit from baseline to end of study over a 12 week period). 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 NCT00709202, which also lists 1 linked publication.

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 25 Jan 2019.

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