ObesityNCT00793780
Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia
A study testing Naltrexone 25mg in people with Obesity and Schizophrenia, run by Yale University at 1 site in United States.
Trial summary
The purpose of this clinical trial is to find out how effective low dose oral naltrexone is on reducing body weight when compared to placebo in women with schizophrenia and schizoaffective disorder. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Obesity, Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Naltrexone 25mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Nov 2010
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between the ages of 18 to 70
- Meet DSM-IV (Diagnostic and Statistical Manual version IV) criteria for schizophrenia or schizoaffective disorder based on SCID (Structured Clinical Interview for the DSM-IV) interview
- Overweight, as defined with a BMI of equal to or greater than 27 kg/m² and continuing weight gain in the past year above 2% of previous years total body weight
- Be on a stable dose of antipsychotic medication; i.e. at least one month with no dosage change, and two months from an antipsychotic switch; 5) Deemed to be symptomatically stable by the clinical staff in the last two months
Who cannot join
- Meet criteria for current alcohol or other substance dependence, opioid use for any reason or positive urine drug screen for opiates
- A history of dementia, mental retardation or other neurological disorder that may interfere with study ratings
- Not capable of giving informed consent for participation in this study
- Ongoing pregnancy
- Known sensitivity to naltrexone
- A medical disorder that is known to cause obesity
Show all 11Show fewer
- Use of sibutramine, topiramate, amphetamines or over the counter weight remedies
- Impaired liver functions (greater than 3 times the upper limit of normal)
- Diagnosed with polycystic ovary syndrome
- Currently being treated with insulin
- Current use of Depo-Provera or any natural/synthetic hormone treatment known to cause significant weight gain
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
The purpose of this clinical trial is to find out how effective low dose oral naltrexone is on reducing body weight when compared to placebo in women with schizophrenia and schizoaffective disorder.
- Conditions
- Obesity, Schizophrenia, Schizoaffective Disorder
- Being tested
- Naltrexone 25mg, Placebo
- Keywords
- obesity, schizophrenia, schizoaffective disorder, weight loss
- Medical subject headings
- Obesity, Schizophrenia, Psychotic Disorders, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone 25mgDrug
Naltrexone 25mg caplets taken orally once a day for 8 weeks
PlaceboOther
Placebo caplet (inactive substance) taken orally once a day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone 25mg | Active comparator | Not described Receives: Drug: Naltrexone 25mg |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight From Baseline
Weight was measured with shoes off to the nearest 0.1 kg.
Measured: 8 weeks
Secondary outcomes (5)
Fasting Serum Glucose Lab Values
Measured: baseline and 8 weeks
PANSS- Positive and Negative Symptom Scale
The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Total score ranges from a minimum of 30 to a maximum of 210. A higher score indicates more severe symptoms.
Measured: 8 weeks
Insulin Levels
Determined with a double-antibody radioimmunoassay
Measured: baseline and week 8
LDL Cholesterol
Determined by standard enzymatic procedures
Measured: baseline and week 8
Change in Questionnaire on Craving for Sweet or Rich Foods Score
The Questionnaire on Craving for Sweet or Rich Foods (QCSRF) is a 2-factor, 9-item scale assessing the presence of cravings for rich and sweet foods and has been found to have good psychometric properties. The total score is the total of 2 sub scales. Total range is from 9 to 63, with a higher score indicative of a higher craving and reinforcement from sweet and/or rich foods.
Measured: baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionNov 2010
- Study completionNov 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Ethel F. Donaghue Women's Health Investigator Program at Yale
- Responsible party
- Sponsor
- Investigators
- Cenk Tek, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793780
- Sponsor's protocol ID
- 0808004106
- Status last verified
- Aug 2016
- First submitted
- 18 Nov 2008
- Last updated
- 6 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tek C, Ratliff J, Reutenauer E, Ganguli R, O'Malley SS. A randomized, double-blind, placebo-controlled pilot study of naltrexone to counteract antipsychotic-associated weight gain: proof of concept. J Clin Psychopharmacol. 2014 Oct;34(5):608-12. doi: 10.1097/JCP.0000000000000192.
PubMed 25102328
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia
- ClinicalTrials.gov ID
- NCT00793780
- Acronym / sponsor ID
- 0808004106
- Conditions
- Obesity, Schizophrenia, Schizoaffective Disorder
- Keywords
- obesity, schizophrenia, schizoaffective disorder, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Ethel F. Donaghue Women's Health Investigator Program at Yale
- Study start
- Dec 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 Nov 2008 (estimated)
- Results
- Posted 6 Oct 2016
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 clinical trial is to find out how effective low dose oral naltrexone is on reducing body weight when compared to placebo in women with schizophrenia and schizoaffective disorder.
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 |
|---|---|---|
| Naltrexone 25mg | Active comparator | Drug: Naltrexone 25mg |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women between the ages of 18 to 70
- Meet DSM-IV (Diagnostic and Statistical Manual version IV) criteria for schizophrenia or schizoaffective disorder based on SCID (Structured Clinical Interview for the DSM-IV) interview
- Overweight, as defined with a BMI of equal to or greater than 27 kg/m² and continuing weight gain in the past year above 2% of previous years total body weight
- Be on a stable dose of antipsychotic medication; i.e. at least one month with no dosage change, and two months from an antipsychotic switch; 5) Deemed to be symptomatically stable by the clinical staff in the last two months
Key exclusion criteria (11 listed)
- Meet criteria for current alcohol or other substance dependence, opioid use for any reason or positive urine drug screen for opiates
- A history of dementia, mental retardation or other neurological disorder that may interfere with study ratings
- Not capable of giving informed consent for participation in this study
- Ongoing pregnancy
- Known sensitivity to naltrexone
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 |
|---|---|---|
| Naltrexone 25mgNaltrexone 25mg caplets taken orally once a day for 8 weeks | Drug | Naltrexone 25mg |
| PlaceboPlacebo caplet (inactive substance) taken orally once a day for 8 weeks | Other | Placebo |
Primary outcome
Change in Body Weight From Baseline
Time frame: 8 weeks
Weight was measured with shoes off to the nearest 0.1 kg.
5 secondary outcomes
Fasting Serum Glucose Lab Values
Time frame: baseline and 8 weeks
PANSS- Positive and Negative Symptom Scale
Time frame: 8 weeks
Insulin Levels
Time frame: baseline and week 8
LDL Cholesterol
Time frame: baseline and week 8
Change in Questionnaire on Craving for Sweet or Rich Foods Score
Time frame: baseline and week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25102328Tek C, Ratliff J, Reutenauer E, Ganguli R, O'Malley SS. A randomized, double-blind, placebo-controlled pilot study of naltrexone to counteract antipsychotic-associated weight gain: proof of concept. J Clin Psychopharmacol. 2014 Oct;34(5):608-12. doi: 10.1097/JCP.0000000000000192.
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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.
Cenk Tek, M.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naltrexone 25mg in people with Obesity and Schizophrenia, run by Yale University 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 11 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 6 Oct 2016. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2016). 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 Body Weight From Baseline (time frame: 8 weeks). 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 NCT00793780, 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 6 Oct 2016.