Weight GainPhase 4NCT01962402
Lorcaserin for Weight Loss Management in Patients on Antipsychotics: A Pilot Study
A Phase 4 study testing lorcaserin and Intensive dietary counseling in people with Weight Gain, run by Southern California Institute for Research and Education at 1 site in United States.
Trial summary
The purpose of this study is to determine whether lorcaserin is effective for weight reduction in patients with weight gain as a result of antipsychotic medications. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Weight Gain
- What is being tested?
- lorcaserin and Intensive dietary counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jul 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Patients currently on atypical antipsychotics
- The patient's BMI is greater than or equal to 30 kg/m2 OR the patient's BMI is greater than or equal to 27 kg/m2 in the presence of at least one weight-related co-morbidity such as hypertension, type 2 diabetes mellitus, dyslipidemia, metabolic syndrome, obstructive sleep apnea, or degenerative joint disease such as osteoarthritis.
- Patient agreeable to follow up with provider at the scheduled appointments at week 1, week 2, week 4, week 8, week 12 and week 16 after initiation of medication.
Who cannot join
- Pregnancy in women or breastfeeding
- The patient has greater than mild aortic valve regurgitation, or moderate to greater mitral valve regurgitation
- Known hypersensitivity to lorcaserin
- The patient is taking another weight loss medication concurrently
- Dementia
- Age less than 18 or greater than 65
Show all 9Show fewer
- No recent substance abuse within 3 months
- No suicidal ideation within 3 months
- Unable to give informed consent, unless patient is conserved, then the conservator can provide informed consent
Trial locations and contacts
1 site in 1 country.
Charles Nguyen, MD contact
United States1 site, 1 recruiting
- Recruiting
VA Long Beach
Long Beach, California, 90822
Susan Shakib, Pharm.D., 562-826-8000 ext. 4564, susan.shakib@va.gov
About this study
The purpose of this study is to determine whether lorcaserin is effective for weight reduction in patients with weight gain as a result of antipsychotic medications.
- Conditions
- Weight Gain
- Being tested
- lorcaserin, Intensive dietary counseling
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lorcaserinDrug
Also called Belviq
Patients will receive lorcaserin 10mg tablet, 1 tablet twice daily for 12 weeks.
Intensive dietary counselingBehavioural
All patients in the study will receive intensive dietary counseling, encouraging eating minimal carbohydrates and sugars.
| Study group | Role | What they receive |
|---|---|---|
| Lorcaserin with intensive diet counseling | Experimental | Patients will be taking lorcaserin 10mg tablet by mouth twice daily. In addition, patients will be provided with intensive dietary counseling to promote weight loss. Receives: Drug: lorcaserin; Behavioral: Intensive dietary counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
The primary objective of this study is to evaluate the effectiveness of lorcaserin for weight loss management in patients on an antipsychotic agent. Will monitor the weight of the patient for evaluation.
Measured: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Secondary outcomes (12)
Evaluation of glucose control
Will evaluate lab values for fasting blood glucose, Hemoglobin A1c, and fasting insulin levels
Measured: At initial visit and at week 12 of the study
Evaluation of cravings
Using various questionnaires to evaluate cravings of various foods.
Measured: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Monitoring of mood
Using standard questionnaires to evaluate mental health.
Measured: At initial visit, then at week 4 and week 12 of the study
Evaluation of systolic blood pressure
Measured: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of diastolic blood pressure
Measured: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of pulse
Measured: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of body-mass index (BMI)
Measured: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of waist circumference
Measured: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of cholesterol control
Will measure fasting cholesterol labs, which will include total cholesterol, triglycerides, low-density lipoprotein (LDL), and high-density lipoprotein (HDL)
Measured: At initial visit and at week 12 of the study
Evaluation of electrolytes
Will monitor basic metabolic panel
Measured: At initial visit and at week 12 of the study
Evaluation of liver
Will monitor liver enzymes
Measured: At initial visit and at week 12 of the study
Evaluation of blood count
Will monitor blood count
Measured: At initial visit and at week 12 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startJan 2014
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern California Institute for Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Nguyen, Southern California Institute for Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962402
- Sponsor's protocol ID
- VALB-1259
- Status last verified
- Jan 2014
- First submitted
- 8 Oct 2013
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lorcaserin for Weight Loss Management in Patients on Antipsychotics: A Pilot Study
- ClinicalTrials.gov ID
- NCT01962402
- Acronym / sponsor ID
- VALB-1259
- Conditions
- Weight Gain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Southern California Institute for Research and EducationUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2015 (estimated)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether lorcaserin is effective for weight reduction in patients with weight gain as a result of antipsychotic medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lorcaserin with intensive diet counseling | Experimental | Drug: lorcaserin, Behavioral: Intensive dietary counselingPatients will be taking lorcaserin 10mg tablet by mouth twice daily. In addition, patients will be provided with intensive dietary counseling to promote weight loss. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients currently on atypical antipsychotics
- The patient's BMI is greater than or equal to 30 kg/m2 OR the patient's BMI is greater than or equal to 27 kg/m2 in the presence of at least one weight-related co-morbidity such as hypertension, type 2 diabetes mellitus, dyslipidemia, metabolic syndrome, obstructive sleep apnea, or degenerative joint disease such as osteoarthritis.
- Patient agreeable to follow up with provider at the scheduled appointments at week 1, week 2, week 4, week 8, week 12 and week 16 after initiation of medication.
Key exclusion criteria (9 listed)
- Pregnancy in women or breastfeeding
- The patient has greater than mild aortic valve regurgitation, or moderate to greater mitral valve regurgitation
- Known hypersensitivity to lorcaserin
- The patient is taking another weight loss medication concurrently
- Dementia
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 |
|---|---|---|
| lorcaserinAlso: BelviqPatients will receive lorcaserin 10mg tablet, 1 tablet twice daily for 12 weeks. | Drug | Lorcaserin with intensive diet counseling |
| Intensive dietary counselingAll patients in the study will receive intensive dietary counseling, encouraging eating minimal carbohydrates and sugars. | Behavioural | Lorcaserin with intensive diet counseling |
Primary outcome
Weight loss
Time frame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
The primary objective of this study is to evaluate the effectiveness of lorcaserin for weight loss management in patients on an antipsychotic agent. Will monitor the weight of the patient for evaluation.
12 secondary outcomes
Evaluation of glucose control
Time frame: At initial visit and at week 12 of the study
Evaluation of cravings
Time frame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Monitoring of mood
Time frame: At initial visit, then at week 4 and week 12 of the study
Evaluation of systolic blood pressure
Time frame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of diastolic blood pressure
Time frame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of pulse
Time frame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of body-mass index (BMI)
Time frame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of waist circumference
Time frame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of cholesterol control
Time frame: At initial visit and at week 12 of the study
Evaluation of electrolytes
Time frame: At initial visit and at week 12 of the study
Evaluation of liver
Time frame: At initial visit and at week 12 of the study
Evaluation of blood count
Time frame: At initial visit and at week 12 of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2014.
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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.
Charles Nguyen, MD contact
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 lorcaserin and Intensive dietary counseling in people with Weight Gain, run by Southern California Institute for Research and Education 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 3 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: status not confirmed, as of the sponsor's last update on 30 Jan 2014. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susan Shakib, Pharm.D. (562-826-8000 ext. 4564, susan.shakib@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2014.