Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial

NCT06303076 | Not Yet Recruiting Phase 4

• 1 other identifier: 134
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study's primary objective is to evaluate the effectiveness of Tinazidine compared to Zolpidem in enhancing sleep quality, with secondary objectives including the assessment of adverse effects, safety profile, and patient tolerance with each treatment. The trial will be conducted as a double-blind RCT, with participants randomly assigned to receive either Tinazidine (0.1 mg/Kg/HS) or Zolpidem 10 mg HS, for 12 weeks. Eligible participants, aged 18-60 years, diagnosed with primary insomnia as per DSM-5 criteria, will be recruited from an outpatient sleep clinic affiliated with Al-Masara Hospital. Data on sleep quality, and side effects, will be collected using the Sleep Pittsburgh Sleep Quality Index (PSQI), Clinical Global Impression (CGI), sleep diaries, actigraphy, polysomnography, and regular clinical interview though OPD follow-up visits. The primary outcome considered was the mean global PSQI score before and after the treatment. The primary outcome will be measured four times (baseline, 4 weeks, 8 weeks, and 12 weeks), We considered an attrition rate (dropout/lost follow-up) of 10%. Therefore, the sample size is 90 subjects (45 in each group). Group comparisons for mean scores will be conducted using independent samples t-tests, and within-group comparisons will be assessed using paired samples t-tests. Changes in sleep quality over time between treatment groups will be evaluated using repeated measures ANOVA. Associations between categorical variables will be examined using Chi-square tests (including Fisher's exact or Likelihood ratio tests as appropriate). Statistical significance will be considered for p-values less than 0.05. All analyses will be performed using IBM SPSS Statistics (Version 29.0). The findings of this study seek to elucidate the comparative efficacy and safety profiles of Tizanidine and Zolpidem in treating primary insomnia. The study aims to offer insights into the effectiveness of Tizanidine versus Zolpidem in improving sleep quality among patients with primary insomnia. Through the evaluation of efficacy, adverse effects, and safety profiles. This study aims to inform clinicians and healthcare practitioners about the optimal treatment choices for individuals with primary insomnia.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index

  Total Items: The PSQI contains a total of 24 questions. Range of Component Scores: Each component score ranges from 0 to 3 points. A score of 0 indicates no difficulty. A score of 3 indicates severe difficulty. Global PSQI Score: The seven component scores are summed to yield one "global" score. Range: The global score ranges from 0 to 21 points. A global score of 0 suggests no difficulty in any areas. A global score of 21 suggests severe difficulties in all areas. Interpretation of the Global Score: The global PSQI score is used to evaluate an individual's sleep quality. A global score greater than 5 often indicates significant sleep disturbances or poor sleep quality.

  Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary Outcomes (1)

• Frequency and Severity of Side Effects

  4 weeks, 8 weeks, 12 weeks

Study Arms (2)

Tizanidine Group

EXPERIMENTAL

Participants will be asked to ingest Tinazidine, orally at home immediately before going to bed to sleep. Initially, the patients will be asked to ingest 2 mg HS, and it will be titrated up by 2 mg every 4 days, as per response and tolerability, up to a maximum dose of 0.1 mg/kg/HS.

Drug: Tizanidine Hcl 4Mg Tab

Zolpidem Group

ACTIVE COMPARATOR

Participants will be asked to ingest Zolpidem 10 mg HS, orally at home before bedtime.

Drug: Zolpidem Tartrate 10 mg

Interventions

Tizanidine Hcl 4Mg Tab DRUG

Initial Dose Administration: Patients will start by taking an initial dose of 2 mg of Tizanidine at bedtime (HS). Dose Titration Process: Every 4 days, the dose of Tizanidine will be increased by 2 mg. This titration is based on the patient's response to the medication and their tolerability of it. Maximum Dose Limit: The dose titration will continue until reaching the maximum dose of 0.1 mg/kg/HS, or until the maximum tolerated dose is identified, whichever comes first. Monitoring and Adjustment: Throughout the titration process, patients will be closely monitored for any adverse effects and for the effectiveness of the medication. Adjustments to the dosing schedule may be made based on the clinician's assessment of tolerability and therapeutic response.

Tizanidine Group

Zolpidem Tartrate 10 mg DRUG

nitial Dose Administration: Participants will start by taking an initial dose of Zolpidem 5 mg orally at home before bedtime (HS). Response Evaluation and Dose Adjustment: If there is no response to the initial 5 mg dose and it is tolerated well by the participant, the dose will be increased to 10 mg. Monitoring and Adjustment: Participants will be monitored for their response to the medication as well as for any adverse effects. The decision to increase the dose to 10 mg will be based on the absence of a therapeutic response to the initial dose and the participant's tolerability of Zolpidem. Dose Maximization and Safety: The increase to a 10 mg dose is aimed at maximizing therapeutic efficacy while ensuring the safety and tolerability of the medication in participants who do not respond to the lower dose.

Zolpidem Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age and Gender Adult participants of either gender, aged 18-60 years old.
• Diagnosis: Diagnosed with primary insomnia by a psychiatry specialist, based on DSM-5 criteria.
• Consent: Able to provide written informed consent.
• Compliance: Willing to comply with study procedures and follow-up assessments.
• Medical Clearance: Participants must undergo a medical checkup by a medical officer affiliated with Al-Masarah Hospital before the randomization process. This checkup includes:
• Medical history review.
• Physical examination, including ECG.
• Vital signs check.
• Random blood sugar test.
• Laboratory evaluation (CBC, LFT, RFT, TFT, Lipid profile).
• Enrollment: Receiving medical clearance for enrollment in the study.

You may not qualify if:

• Secondary Insomnia: Individuals diagnosed with secondary insomnia.
• Substance Abuse History: Those with a history of substance abuse.
• Significant Medical or Psychiatric Disorders: Individuals diagnosed with significant and/or unstable medical or psychiatric disorders or mental retardation.
• Pregnancy or Lactation: Pregnant or lactating mothers, or those of childbearing potential not using an adequate method of contraception (excluding natural birth spacing methods).
• Drug Allergy: Known hypersensitivity or allergy to Tinazidine or Benzodiazepines.
• Communication Barriers: Individuals unable to understand or communicate with researchers.
• Recent Participation in Clinical Trials: Those who have participated in other clinical trials involving investigational drugs within the past 30 days before participation.
• Recent Use of Sleep Medication: Participants must not have taken any over-the-counter or prescription sleep medication within the past 30 days before participation.
• Use of Substances Affecting CNS: No intake of any substance with central nervous system (CNS) effects known to affect sleep within 30 days before participation.

Sponsors & Collaborators

• Sultan Qaboos University: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

tizanidine; Zolpidem

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Mohammed Al Alawi, MD PhD

CONTACT

+96892281145; alalawim@squ.edu.om

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Mohmmed Al Alawi Bsc, MD,PhD, MRCPsych, OMSBPsych, ARABPsych

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share