Tardive DyskinesiaNCT01391390

Melatonin Treatment for Tardive Dyskinesia in Schizophrenia

A study testing Melatonin in people with Tardive Dyskinesia, run by Beijing HuiLongGuan Hospital at 1 site in China.

Completed

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

Trial summary

This is a double-blind, randomized, placebo-controlled trial of melatonin as an add-on therapy to antipsychotics will be performed to examine the effects of melatonin on tardive dyskinesia symptoms and cognitive deficits in 120 patients with established tardive dyskinesia (TD). Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Tardive Dyskinesia
What is being tested?: Melatonin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteChina
Study dates: Sep 2008to May 2011
Phase: Interventional
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

diagnosis of both schizophrenia and TD;
duration of TD symptoms longer than 1 year;
on stable doses of antipsychotic drug for at least 6 months;
between 18 and 70 years of age.

Who cannot join

comorbid neurological illness other than TD;
if they have received vitamin C or vitamin E within 1 month before the start of the study;
alcohol/drug abuse;
acute, unstable medical condition;
pregnant or breastfeeding female;
use of other antioxidants.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing HuiLongGuan hospital
Beijing, 100096

Other trials in China

About this study

Official title: The Effect of Melatonin Treatment on Tardive Dyskinesia and Oxidative Stress: A Double-Blind Placebo-Controlled Trial

Read the detailed description

Since it has been proposed that neuroleptic-induced increases in free-radical production may relate to the development of TD, the investigators hypothesize that melatonin, an effective antioxidant, may attenuate the severity of tardive dyskinesia symptoms.
Due to increased cognitive deficits in patients with TD and implication of oxidative stress in cognitive impairment, the investigators hypothesize that both cognitive impairment and tardive dyskinesia symptoms may be induced by the same pathophysiological stimulus--oxidative stress. Hence, the investigators further hypothesize that both tardive dyskinesia symptoms and cognitive deficits in patients with TD may be improved by melatonin simultaneously.

Conditions: Tardive Dyskinesia
Being tested: Melatonin, Placebo
Keywords: Tardive Dyskinesia, Schizophrenia, Melatonin, Oxidative Stress, Antioxidant
Medical subject headings: Tardive Dyskinesia, Schizophrenia

What participants receive

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

MelatoninDrug
Also called APRD00742
10mg/day, 12-week treatment
PlaceboDrug
10mg/day, 12-week treatment for TD

Study groups in NCT01391390
Study group	Role	What they receive
Melatonin, antioxidant, oxidative stress	Experimental	Melatonin is an active treatment for TD. Receives: Drug: Melatonin
Placebo	Placebo comparator	Placebo look like the active drug, and same dose. Receives: Drug: Placebo

What is being measured

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

the Abnormal Involuntary Movement Scale (AIMS)
Measured: 12 weeks

Secondary outcomes (3)

the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Measured: 12 weeks
the Positive and Negative Syndrome Scale (PANSS)
Measured: 12 weeks
the Simpson-Angus Scale for extrapyramidal side effects (SAS)
Measured: 12 weeks

Timeline

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

Sep 2008May 2011

First posted12 Jul 2011 (estimated)
Study startSep 2008
Primary completionApr 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Tardive DyskinesiaStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01391390
Sponsor's protocol ID: BJ-7072035
Status last verified: Jul 2016
First submitted: 7 Jul 2011
Last updated: 12 Jul 2016
Results posted: No
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

RecruitingPhase 4
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Schizophrenia, Schizoaffective Disorder
Not yet recruitingObservational study
A Computer-Assisted Tool for Objective Assessment of Extrapyramidal Symptoms
Extrapyramidal Symptoms, Drug-induced Parkinsonism
RecruitingPhase 4
Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities
Tardive Dyskinesia, Intellectual Disability
RecruitingPhase 2
Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia
Tardive Dyskinesia
Recruiting
Single-Center, Double-Blind, Randomized, Placebo-Controlled Study on Efficacy and Safety of rTMS (With Precise Localization) in Relieving Motor Symptoms of TD
Tardive Dyskinesia, Repetitive Transcranial Magnetic Stimulation

All Tardive Dyskinesia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Melatonin Treatment on Tardive Dyskinesia and Oxidative Stress: A Double-Blind Placebo-Controlled Trial
ClinicalTrials.gov ID: NCT01391390
Acronym / sponsor ID: BJ-7072035
Conditions: Tardive Dyskinesia
Keywords: Tardive Dyskinesia, Schizophrenia, Melatonin, Oxidative Stress, Antioxidant
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Beijing HuiLongGuan HospitalUniversity, hospital or other
Collaborators: Stanley Medical Research Institute
Study start: Sep 2008
Primary completion: Apr 2011 (actual)
Study completion: May 2011 (actual)
First posted: 12 Jul 2011 (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.

Detailed description

Since it has been proposed that neuroleptic-induced increases in free-radical production may relate to the development of TD, the investigators hypothesize that melatonin, an effective antioxidant, may attenuate the severity of tardive dyskinesia symptoms.
Due to increased cognitive deficits in patients with TD and implication of oxidative stress in cognitive impairment, the investigators hypothesize that both cognitive impairment and tardive dyskinesia symptoms may be induced by the same pathophysiological stimulus--oxidative stress. Hence, the investigators further hypothesize that both tardive dyskinesia symptoms and cognitive deficits in patients with TD may be improved by melatonin simultaneously.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Melatonin, antioxidant, oxidative stress	Experimental	Drug: MelatoninMelatonin is an active treatment for TD.
Placebo	Placebo comparator	Drug: PlaceboPlacebo look like the active drug, and same dose.

Who may qualify

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

Key inclusion criteria (4 listed)

diagnosis of both schizophrenia and TD;
duration of TD symptoms longer than 1 year;
on stable doses of antipsychotic drug for at least 6 months;
between 18 and 70 years of age.

Key exclusion criteria (6 listed)

comorbid neurological illness other than TD;
if they have received vitamin C or vitamin E within 1 month before the start of the study;
alcohol/drug abuse;
acute, unstable medical condition;
pregnant or breastfeeding female;

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
MelatoninAlso: APRD0074210mg/day, 12-week treatment	Drug	Melatonin, antioxidant, oxidative stress
Placebo10mg/day, 12-week treatment for TD	Drug	Placebo

Primary outcome

the Abnormal Involuntary Movement Scale (AIMS)
Time frame: 12 weeks

3 secondary outcomes

the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: 12 weeks
the Positive and Negative Syndrome Scale (PANSS)
Time frame: 12 weeks
the Simpson-Angus Scale for extrapyramidal side effects (SAS)
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.

Related trials for Tardive Dyskinesia

RecruitingPhase 4
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Schizophrenia, Schizoaffective Disorder
Not yet recruitingObservational study
A Computer-Assisted Tool for Objective Assessment of Extrapyramidal Symptoms
Extrapyramidal Symptoms, Drug-induced Parkinsonism
RecruitingPhase 4
Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities
Tardive Dyskinesia, Intellectual Disability
RecruitingPhase 2
Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia
Tardive Dyskinesia
Recruiting
Single-Center, Double-Blind, Randomized, Placebo-Controlled Study on Efficacy and Safety of rTMS (With Precise Localization) in Relieving Motor Symptoms of TD
Tardive Dyskinesia, Repetitive Transcranial Magnetic Stimulation

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.

Lian Y Cao, MD study chair

Beijing HuiLongGuan Hospital

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

Questions about this trial

What is this clinical trial studying?

A study testing Melatonin in people with Tardive Dyskinesia, run by Beijing HuiLongGuan Hospital at 1 site in China.

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 6 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 12 Jul 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

the Abnormal Involuntary Movement Scale (AIMS) (time frame: 12 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 NCT01391390.

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 12 Jul 2016.